Considering attending the 20th annual Florida Medical Device Symposium May 11-12, 2027, at USF Health’s Center for Advanced Medical Learning and Simulation (CAMLS) in the heart of downtown Tampa. The annual symposium is Florida’s premier event for medical device manufacturing firms, featuring FDA speakers, expert panels on regulatory issues and industry trends, exhibiting companies, legislative...Read More
Our General Manager, Brian Pate, will be co-teaching the 3-Day AAMI Software Validation course on October 27-29, 2026 from 9:00 am to 6:00 pm Eastern Time. This class will ground you in all the relevant regulations, standards and guidance and help you understand how risk, cybersecurity, cloud computing and mobile apps impact the medical device...Read More
Company: Beckman Coulter Inc. Date of Enforcement Report: 10/2/2026 Class: II PRODUCT DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520 Recall Number: Z-0084-2027 REASON: Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration...Read More
Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: 9/29/2026 Class: II PRODUCT: Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No Recall Number: Z-3330-2026 REASON: A beta (early-release) version of the iOS application, version 2.13...Read More
Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 9/25/2026 Class: II PRODUCT Computed Tomography X-ray System, Model: uCT 550 with software Recall Number: Z-3278-2026 REASON: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a...Read More
Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 9/25/2026 Class: II PRODUCT Computed Tomography X-ray System, Model: uCT 530 with software Recall Number: Z-3277-2026 REASON: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a...Read More
Company: Volcano Corp Date of Enforcement Report: 9/25/2026 Class: II PRODUCT Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA Recall Number: Z-3276-2026 REASON: Software system may associate image data from one patient with another patient’s record, potentially resulting in incorrect diagnosis or treatment. RECALLING FIRM/MANUFACTURER: Volcano Corp VOLUME: 19 systems DISTRIBUTION: Worldwide –...Read More
“It’s Déjà Vu All Over Again” as United Kingdom (UK) flights face disruption … again. A recurring UK (and international) traveler nightmare On September 21st, disruptions again are affecting flights in/to/from the UK. As in the major September 8th outage, the cause is a “technical issue” in the National Air Traffic Services (NATS) systems that...Read More
Company: Philips Ultrasound, LLC Date of Enforcement Report: 9/18/2026 Class: II PRODUCT Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 Recall Number: Z-3249-2026 REASON: Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis. RECALLING FIRM/MANUFACTURER: Philips Ultrasound,...Read More
Company: Nova Biomedical Corporation Date of Enforcement Report: 9/11/2026 Class: I PRODUCT StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. Recall Number: Z-3130-2026 REASON: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification...Read More
Company: Philips North America Date of Enforcement Report: 9/11/2026 Class: II PRODUCT Philips Patient Information Center iX REF:866389 Recall Number: Z-3141-2026 REASON: Due to software malfunction, patient information system may freeze and become unresponsive. RECALLING FIRM/MANUFACTURER: Philips North America VOLUME: 7359 Units DISTRIBUTION: Worldwide – US Nationwide distribution including in the states and territories of...Read More
Company: Nova Biomedical Corporation Date of Enforcement Report: 9/11/2026 Class: I PRODUCT StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. Recall Number: Z-3128-2026 REASON: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID)...Read More
In this article we will take a look at what is new in the 2026 version of the FDA guidance document, “General Wellness: Policy for Low Risk Devices.” Recent history of FDA’s regulation of general wellness products: In 2016. section 3060(a) of the Cures Act amended section 520 of the FD&C Act to remove certain...Read More
Company: Boston Scientific Corporation Date of Enforcement Report: 9/2/2026 Class: II PRODUCT LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7) Recall Number: Z-3082-2026 REASON: There is potential for a delay in AF Burden Alert notification affecting the server software which supports...Read More
Company: Medos International Sarl Date of Enforcement Report: 9/2/2026 Class: II PRODUCT Velys Enabling Tech Robotic-Assist Station REF: 451611001 Recall Number: Z-3088-2026 REASON: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. RECALLING FIRM/MANUFACTURER: Medos International Sarl VOLUME: 29 stations DISTRIBUTION: US Nationwide distribution...Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/31/2026 Class: II PRODUCT Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS Recall Number: Z-3065-2026 REASON: A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains RECALLING FIRM/MANUFACTURER: Baxter...Read More
Company: GE Medical Systems Information Technologies Inc Date of Enforcement Report: 8/27/2026 Class: II PRODUCT: PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 Recall Number: Z-3036-2026 REASON: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the...Read More
Company: FUJIFILM Healthcare Americas Corporation Date of Enforcement Report: 8/26/2026 Class: II PRODUCT: FUJIFILM Synapse PACS software v7.4.310; radiological image processing system Recall Number: Z-3030-2026 REASON: Software issue may cause the ruler measurement to be inaccurate. RECALLING FIRM/MANUFACTURER: FUJIFILM Healthcare Americas Corporation VOLUME: 6 units DISTRIBUTION: Worldwide – US Nationwide distribution in the states of...Read More
