Guiding clients to effective and efficient compliance and regulatory approvals

Company: Philips North America Llc. Date of Enforcement Report: 10/4/2024 Class II PRODUCT IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there...
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Company: Boston Scientific Corporation Date of Enforcement Report: 10/16/2024 Class II PRODUCT Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral...
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Company: Agfa Healthcare NV Date of Enforcement Report: 10/10/2024 Class II PRODUCT Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 10/10/2024 Class II PRODUCT StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Recall Number: Z-0050-2025 REASON: Due to two...
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(Tampa, FL, October 9, 2024) – Crisis Prevention and Recovery, LLC is taking proactive steps to minimize impact to our clients from the landfall of Hurricane Milton in Southwest Florida.  With our corporate office in Tampa, Florida, there is a possibility of short term loss of electrical power and/or internet in the next 24 to...
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Company: Zyno Medical LLC Date of Enforcement Report: 10/9/2024 Class II PRODUCT Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z Recall Number: Z-0005-2025 REASON: There is a defect in the air-in-line software algorithm. RECALLING FIRM/MANUFACTURER: Zyno...
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Company: Beckman Coulter, Inc. Date of Enforcement Report: 10/07/2024 Class II PRODUCT Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. Recall Number: Z-0025-2025 REASON: When the DxI 9000 Access Immunoassay Analyzer with...
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Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/03/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...
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Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/3/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...
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Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...
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Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 9/24/2024 Class II PRODUCT ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software. Recall Number: Z-3215-2024 REASON: If ultrasound systems with software, are changed from factory default to :...
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Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3135-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...
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Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3134-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...
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Company: Mazor Robotics Ltd Date of Enforcement Report: 9/16/2024 Class II PRODUCT Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Recall Number: Z-3156-2024 REASON: Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw...
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Company: Philips Respironics, Inc. Date of Enforcement Report: 9/4/2024 Class I PRODUCT Trilogy Evo EV300 — Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA...
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Company: Medtronic Inc. Date of Enforcement Report: 9/13/2024 Class II PRODUCT 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description:...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 8/30/2024 Class: II PRODUCT BD Pyxis QFill Replenishment Station, REF: 138904-01 Recall Number: Z-2947-2024 REASON: Due to software issue, their is a potential when a restock label is printed for a medication stored in a non-CUBIE location, the incorrect bin for the medication is printed on the...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 8/30/2024 Class II PRODUCT BD Pyxis QFill Replenishment Station, REF: 138904-01 Recall Number: Z-2947-2024 REASON: Due to software issue, their is a potential when a restock label is printed for a medication stored in a non-CUBIE location, the incorrect bin for the medication is printed on the...
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WARNING LETTER Globus Medical, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 685606 Globus Medical, Inc. Valley Forge Business Center2560 General Armistead Avenue Audubon, PA 19403 Dates: February 15, 2024, through March 7, 2024 Inspection Issue(s): These violations include, but are not limited to, the...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/16/2024 Class II PRODUCT Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump. Recall Number: Z-2581-2024 REASON: The Spectrum WBM may fail to auto-document...
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Company: Biointellisense Inc. Date of Enforcement Report: 8/14/2024 Class II PRODUCT BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. Recall Number: Z-2616-2024 REASON: Software anomaly causing the skin temperature...
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Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/9/2024 Class II PRODUCT Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. Recall Number: Z-2544-2024 REASON: The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the...
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Company: Philips North America Llc Date of Enforcement Report: 8/5/2024 Class II PRODUCT IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. Recall...
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 8/2/2024 Class: I PRODUCT CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent...
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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:  TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

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

Registration Link:

TBD

 


 

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: TBD

 


 

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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