SoftwareCPR’s partner Dr. Peter Rech convened the IEC TC62/SC62D/MT23 Infusion Pumps working group meeting held from April 22nd to 26th at the AAMI headquarters in Arlington, VA. The attendants included international experts and guests joining from governmental agencies, infusion pump manufacturers, test houses, and clinical research institutions. Progress was made on a variety topics: Pump...Read More
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 5/24/2024 Class II PRODUCT Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100. Recall Number: Z-1895-2024 REASON: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does...Read More
Company: Stryker Leibinger GmbH & Co. KG Date of Enforcement Report: 5/23/2024 Class II PRODUCT 8000-021-002, Scopis ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic...Read More
Company: Tornier S.A.S. Date of Enforcement Report: 5/22/2024 Class II PRODUCT Stryker Blueprint Software, Catalog #BPUE001 Recall Number: Z-1883-2024 REASON: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval. RECALLING FIRM/MANUFACTURER: Tornier S.A.S....Read More
Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: May 06, 2024 Class I PRODUCT t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology version 2.7 or later /UDI: 00850006613274 Recall Number: Z-1609-2024 REASON: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the...Read More
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 5/9/2024 Class I PRODUCT Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Recall Number: Z-1776-2024 REASON: Due to a software issue, there is the potential for...Read More
WARNING LETTER CMS# 675673 Cue Health, Inc. San Diego, CA May 9, 2024 Inspection Dates: on 10 dates between October 17, 2023 and November 3, 2023. Inspection Issue(s): “not complying with the following Conditions of Authorization in the Letters of Authorization for EUA200248 and EUA210180. For example: Evidence obtained during the inspection demonstrated that your...Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 5/1/2-24 Class II PRODUCT RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System Recall Number: Z-1742-2024 REASON: Potential for reported SSD to be too high. RECALLING FIRM/MANUFACTURER: RAYSEARCH LABORATORIES AB VOLUME OF PRODUCT IN COMMERCE: 9 units DISTRIBUTION: Worldwide distribution – US Nationwide and the countries of Algeria,...Read More
Company: SonarMed Inc Date of Enforcement Report: April 19, 2024 Class I PRODUCT AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. Recall Number: Z-1426-2024 REASON: SonarMed Inc. is recalling the SonarMed Airway monitoring system because of a software issue resulting in failure to detect a partial obstruction within 2.5mm sensors...Read More
We are pleased to announce our SoftwareCPR® Partner, Dr. Peter Rech, will lead the international working group meeting of IEC TC62/SC62D/MT23 Infusion Pumps as its Convenor. The meeting will be hosted by AAMI at the AAMI headquarters from April 22nd to 25th, 2024, in Arlington, VA. The meeting will be dedicated to the maintenance of...Read More
The FDA announced today that a Federal District Court has entered a Consent Decree Against Philips Respironics following recall of certain sleep therapy machines. The consent decree includes key provisions aimed to prioritize patient relief and ensure the company’s regulatory compliance. The consent decree comes after Philips recalled certain ventilators, continuous positive airway pressure (CPAP)...Read More
The DEFENSE IN DEPTH approach is to defend the system against any particular ATTACK using several independent methods. Often these might be referred to as “layers of protection.” Some have described it as the “swiss cheese slices” approach – there may be holes in each layer, but when stacked together they form a protective barrier....Read More
The U.S. Food and Drug Administration, Center for Devices and Radiological Health announced today that they had qualified a new tool for the evaluation of lethal arrhythmia alarm detection algorithms used in hospital-based patient monitoring systems (UCSF LAD MDDT), through the Medical Device Development Tools (MDDT) program. The University of California San Francisco (UCSF) Lethal...Read More
Company: Life Technologies Corporation Date of Enforcement Report: 3/29/2024 Class II PRODUCT Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx...Read More
Guidance Update: FDA revises Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The FDA released a revised draft of the Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program on 15 March, 2024. When finalized, this guidance will supersede both the current version of...Read More
Use of master files can be a convenient and strategic method for SaMD manufacturers or software suppliers to provide information necessary for a US regulatory submission without disclosing confidential and/or proprietary trade secrets to business partners. For example, a software supplier of a cloud library providing medical device functionality could submit a master file to...Read More
Company: Landauer Date of Enforcement Report: 3/21/2024 Class II PRODUCT microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059 Recall Number: Z-1349-2024 REASON: Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove...Read More
Company: Philips Respironics, Inc. Date of Enforcement Report: March 19, 2024 Class I PRODUCT Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal Recall Number: Z-1502-2024 REASON: Philips Respironics, Inc. has notified customers to update to the latest software version (1.05.06.00) of its Trilogy Evo continuous ventilator devices due to a possible power...Read More
Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 3/11/2024 Class II PRODUCT LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Recall Number: Z-1282-2024 REASON: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable...Read More
Company: Fresenius Kabi USA, LLC Date of Enforcement Report: March 7, 2024 Class I PRODUCT LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Recall Number: Z-1484-2024 REASON: Fresenius Kabi USA, LLC. is recalling their Ivenix Infusion System (IIS), LVP Software, an infusion pump software. The recall will take the form of a software...Read More
Today, FDA published a guidance paper for the use of augmented reality (AR) & virtual reality in medical devices. The information from that paper is provide below. Medical Extended Reality (XR), which includes Augmented Reality (AR) and Virtual Reality (VR), has the potential to deliver new types of treatments and diagnostics, transforming how and where...Read More
I (Mike Russell) attended the neXus conference on medical device standards this year. Below are some observations and suggested takeaways from the talks I heard and the panel I was on. Remember, these are just selected highlights, not everything said 🙂 Session: Reducing Submission Rejections and Recalls with Software Standards This year’s conference added a third...Read More
