By

Allison Pate
Company: Philips Healthcare Date of Enforcement Report: 09/29/2023 Class II PRODUCT Incisive CT, software version 5.0 Recall Number: Z-2520-2023 REASON: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 09/29/2023 Class II PRODUCT Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators. Recall Number: Z-2657-2023 REASON: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 09/28/2023 Class II PRODUCT BD Pyxis MedBank MedPass Software, REF: 139088-01 Recall Number: Z-2646-2023 REASON: After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to...
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Company: Baxter Healthcare Corp. Date of Enforcement Report: 09/28/2023 Class II PRODUCT Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x. Recall Number: Z-2647-2023 REASON: Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System...
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Company: Exocad GmbH Date of Enforcement Report:9/25/2023 Class II PRODUCT exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy. Recall Number: Z-2633-2023 REASON: A software library filtering error has been discovered which occurs when...
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Sonesta Medical AB was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for,...
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Company: Diversatek Healthcare Date of Enforcement Report: 09/07/2023 Class III PRODUCT ZVU Functional GI Software, REF: ZVU-3 Recall Number: Z-2521-2023 REASON: GI software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. RECALLING FIRM/MANUFACTURER: Diversatek Healthcare VOLUME OF PRODUCT IN COMMERCE: 20 DISTRIBUTION: Worldwide – US Nationwide distribution in the states...
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Lex Inc. was issued a warning letter from the FDA for reason “of vulnerabilities in hardware and software, encompassing both networked and non-networked systems (e.g., programmable logic controller (PLC)).” More specifically, “a list of all software configurations (both equipment software and laboratory information management system (LIMS)) and versions, details of all user privileges, and oversight...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 08/25/2023 Class II PRODUCT RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0 Recall Number: Z-2464-2023 REASON:...
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Company: Stryker Corporation Date of Enforcement Report: 08/25/2023 Class II PRODUCT SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090. Recall Number: Z-2463-2023 REASON: Potential for current software to miscount when scanning in multiple...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 07/21/2023 Class II PRODUCT A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. Recall Number: Z-2226-2023 REASON: When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application...
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Company: Hamilton Medical, Inc. Date of Enforcement Report: 07/21/2023 Class I PRODUCT HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Recall Number: Z-2139-2023 REASON: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop...
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Company: Digisonics, Inc Date of Enforcement Report: 07/20/2023 Class II PRODUCT Digisonics OBView Versions 4.8.2 SP6 – 4.8.3, Ultrasound reporting software Recall Number: Z-2214-2023 REASON: Software issue RECALLING FIRM/MANUFACTURER: Digisonics, Inc VOLUME OF PRODUCT IN COMMERCE: 32 units DISTRIBUTION: US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY,...
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Company: Beckman Coulter Biomedical GmbH Date of Enforcement Report: 07/14/2023 Class II PRODUCT Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Recall Number: Z-2144-2023 REASON: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 07/13/2023 Class I PRODUCT SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 Recall Number: Z-2103-2023 REASON: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported...
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Tampa, FL, July 13, 2023. Crisis Prevention and Recovery, LLC, dba SoftwareCPR® is pleased to announce that our partner, Dr. Peter Rech, has received the Certified Information Systems Security Professional (CISSP) prestigious certification.  Peter has led the SoftwareCPR staff in cybersecurity related activities for our clients and is one of the premier regulatory experts with...
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In May 2023, FDA centers CDER and CBER released guidance on the integration of risk with quality management.  Per FDA, these “principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.”  The guidance covers the general quality risk management process but discusses the roles and responsibilities...
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ZYTO Technologies was issued a warning letter from the FDA for the reason of “the ZYTO Hand Cradle GSR and associated proprietary software is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act,...
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ZYTO Technologies, Inc. was issued a warning letter from the FDA for reason “your firm is promoting the ZYTO Hand Cradle GSR and associated proprietary software outside its cleared intended use.” More specifically, Our inspection revealed that the ZYTO Hand Cradle GSR and associated proprietary software is adulterated under section 501(f)(1)(B) of the Act, 21...
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Company: RaySearch America Inc Date of Enforcement Report: 07/03/2023 Class II PRODUCT Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Recall Number: Z-2039-2023 REASON: A software bug affecting results when...
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Company: Philips North America Llc Date of Enforcement Report: 06/29/2023 Class II PRODUCT DigitalDiagnost C90, Model No. 712034 and 712035 Recall Number: Z-2042-2023 REASON: There is a software login in issue that may prevent the user from logging in. RECALLING FIRM/MANUFACTURER: Philips North America Llc VOLUME OF PRODUCT IN COMMERCE: 58 DISTRIBUTION: Distribution in US:...
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Company: Appliedvr Date of Enforcement Report: 06/29/2023 Class II PRODUCT RelieVR REF: RVX-2002, Rx Only Recall Number: Z-2044-2023 REASON: There is the potential for the program software to malfunction which will not allow it to move forward to the next session. RECALLING FIRM/MANUFACTURER: Appliedvr VOLUME OF PRODUCT IN COMMERCE: 1 unit DISTRIBUTION: US: NY OUS:...
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Company: SenTec AG Date of Enforcement Report: 06/20/2023 Class II PRODUCT V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). Recall Number: Z-1980-2023 REASON: The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode “production” and were not reset to “released” mode. RECALLING...
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Company: Illumina, Inc. Date of Enforcement Report: 06/16/2023 Class II PRODUCT NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software Recall Number: Z-1976-2023 REASON: Cybersecurity vulnerability concerning the software used for sequencing instruments. RECALLING FIRM/MANUFACTURER: Illumina, Inc. VOLUME OF PRODUCT IN COMMERCE: 1067 units DISTRIBUTION: Worldwide distribution – US Nationwide and the countries...
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Company: Datascope Corp. Date of Enforcement Report: 06/14/2023 Class III PRODUCT Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...
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Company: Datascope Corp. Date of Enforcement Report: 6/14/2023 Class III PRODUCT: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...
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Company: BioReference Health, LLC Date of Enforcement Report: 06/02/2023 Class II PRODUCT The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Recall Number: Z-1666-2023 REASON: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Recall Number: Z-1666-2023 REASON: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance...
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Company: BioReference Health, LLC Date of Enforcement Report: 06/02/2023 Class II PRODUCT The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems Recall Number: Z-1630-2023 REASON: During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other...
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Company: Draeger Medical Systems, Inc. Date of Enforcement Report: 4/27/2023 Class II PRODUCT Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower Recall Number: Z-1471-2023 REASON: The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity...
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Company: Hamilton Medical AG Date of Enforcement Report: 4/25/2023 Class II PRODUCT HAMILTON-C6, REF: 160021 Recall Number: Z-1429-2023 REASON: Software error causes, safety ventilation malfunction, in which ventilation continues in the “safety ventilation” mode with audible/visible alarm – patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode...
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Company: Spacelabs Healthcare, Inc Date of Enforcement Report: 4/12/2023 Class II PRODUCT Ultraview SL (UVSL) Command Module, Model 91496 Recall Number: Z-1503-2023 REASON: Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with...
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Company: Outset Medical, Inc. Date of Enforcement Report: 4/07/2023 Class II PRODUCT Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. Recall Number: Z-1351-2023 REASON: An...
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Company: Shanghai United Imaging Healthcare Co., Ltd Date of Enforcement Report: 4/7/2023 Class II PRODUCT Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057 Recall Number: Z-1353-2023 REASON: Due to a software issue where the process of patient scanning, the scatter correction may...
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(Denis Pasero. Med-Tech News. 3-10-23) Microbatteries in implantable devices are allowing earlier detection along with closer and more regular observation of the patient. A major benefit would be the real-time monitoring of the patient in areas not previously possible due to size, comfort levels, and the complexity of surgery. Much work is still to be...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 3/01/2023 Class II PRODUCT Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255 Recall Number: Z-1192-2023 REASON: Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new...
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Company: Stryker Corporation Date of Enforcement Report: 2/27/2023 Class II PRODUCT Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss. RECALL NUMBER: Z-1184-2023 REASON: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output...
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Company: Getinge Usa Sales Inc Date of Enforcement Report: 1/26/2023 Class I PRODUCT Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400 Programmable Diagnostic Computer Recall Number: Z-0959-2023 REASON Due to a software bug, under certain conditions, pressure cannot be built up resulting in no...
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Company: Align Technology Inc. Date of Enforcement Report: 1/26/2023 Class II PRODUCT Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 Recall Number: Z-1017-2023 REASON 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than...
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(Jim Lynch. Science Daily. University of Michigan. 01-02-2023) New 3D imaging capturing sound waves by X-rays provides the ability to map radiation doses. Doctors are now equipped with real-time data to guide treatments. Prior to this break through, medical professionals were left in the dark as to how much radiation was hitting their target area....
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Company: Agfa Healthcare NV Date of Enforcement Report: 1/20/2023 Class II PRODUCT Agfa HealthCare Enterprise Imaging XERO Viewer Recall Number: Z-0775-2023 REASON There is a software defect that can cause issues with images. RECALLING FIRM/MANUFACTURER Agfa Healthcare NV VOLUME OF PRODUCT IN COMMERCE 110 units DISTRIBUTION Distribution throughout US OUS distribution to Australia, Belgium, Brazil,...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 01/06/2023 Class II PRODUCT Devices Recall Number: Z-0911-2023 REASON Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303” RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation VOLUME OF PRODUCT IN COMMERCE 440 units DISTRIBUTION Worldwide distribution
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(Ann R. Thryft. 11-16-22. Mddionline.com) A team made up of Sensoria Health, Foot Defender, and former Nike shoe designers came together to create a cloud-based patient monitoring boot for Diabetes patients. On the extreme, but very realistic side, this technology could help save patients from requiring an amputation if used correctly after ulcer surgery. The...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 12/31/2022 Class II PRODUCT Programmable Diagnostic Computer Recall Number: Z-0775-2023 REASON The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) “PASSWORD STORE CORRUPTED” error message during system boot;...
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(Med-TechNews, December 12, 2022). Sir Nicholas Wright and Digistain in the UK has created a new tool to aid the early detection of breast cancer. Based on clinical trials, this new development is helping those eligible successfully avoid chemotherapy through earlier and more personalized test results. This allows patients more time to make decisions, less...
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Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report:12/20/202 Class II PRODUCT 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126...
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RightEye, LLC was issued a Warning Letter from the FDA due to “the RightEye Vision System was cleared under K181771 with the following indications: “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.” However, your firm’s promotion of the device provides evidence that the device is intended to...
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(November 8, 2022. Nick Paul Taylor. MedTech Dive) H2o Therapeutics is the company behind the app, Parky, which promises to track Parkinson’s symptoms using an Apple watch. Patients are able to take advantage of Apple’s pre-existing movement disorder API features in their wearables. This can provide valuable and reliable insight to clinicians between visits through...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

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Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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