Company: Impedimed Limited Date of Enforcement Report: 10/24/2023 Class II PRODUCT SOZO Bilateral Arm L-Dex Software Recall Number: Z-0155-2024 REASON: Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could...
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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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AbioMed was issued a warning letter from the FDA for reason “the Impella Connect System device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or...
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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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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: 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: 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: 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: 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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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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(October 6, 2022. Health IT Security) The FDA has issued a user fee re-authorization bill but due to fast approaching deadlines among other constricting legislative factors, the House bill has left out medical device security leaving some experts weary of it’s consequences.
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MicroVention located in Costa Rica was issued a warning letter from the FDA for reason “that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of...
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Company: Baxter Healthcare Company Date of Enforcement Report: 7/22/2022 Class I PRODUCT ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393...
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Company: CHANGE HEALTHCARE CANADA COMPANY Date of Enforcement Report: 10/14/2020 Class II PRODUCT Change Healthcare Radiology Solutions 14.0 Recall Number: Z-0072-2021 REASON Software defect which may potentially result in one or more images missing in a study. RECALLING FIRM/MANUFACTURER CHANGE HEALTHCARE CANADA COMPANY on 8/25/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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FDA has issued a final order to reclassify: medical image analyzers applied to mammography breast cancer ultrasound breast lesions radiograph lung nodules radiograph dental caries detection all which are post-amendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician’s...
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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

Next public offering:  June 5-7, 2024
Boston, MA

Email 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: Tuesday, January 23 through Friday, January 26 from at 11 am – 3 pm EST

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)

Next public offering:  TBD

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