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
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
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
Company: Merge Healthcare, Inc. Date of Enforcement Report: 8/21/2026 Class: II PRODUCT: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation Recall Number: Z-3004-2026 REASON: Software issue may cause measurements to be displayed inaccurately. RECALLING FIRM/MANUFACTURER: Merge Healthcare, Inc. VOLUME: 20 units DISTRIBUTION: US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.Read More
Company: Beckman Coulter Inc. Date of Enforcement Report: 8/17/2026 Class: II PRODUCT Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252;...Read More
Company: Foundation Medicine, Inc. Date of Enforcement Report: 8/14/2026 Class: II PRODUCT Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx. Recall Number: Z-2951-2026 REASON: Software issue that can cause an increase in spontaneous software closures. RECALLING FIRM/MANUFACTURER: Foundation Medicine, Inc. VOLUME: 32 units DISTRIBUTION: US Nationwide distribution...Read More
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 8/10/2026 Class: II PRODUCT Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed...Read More
Company: MUNEVO GMBH Date of Enforcement Report: 7/31/2026 Class: II PRODUCT munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System Recall Number: Z-2856-2026 REASON: A software issue may cause the wheelchair’s driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift...Read More
Company: Copan WASP Date of Enforcement Report: 7/31/2026 Class: II PRODUCT Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked with microbiological specimens derived...Read More
Company: Beckman Coulter Biomedical GmbH Date of Enforcement Report: 7/31/2026 Class: II PRODUCT REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections. Recall Number: Z-2834-2026 REASON: Due to software issues where does not handle combo assay results. The software...Read More
IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software Course Dates/Location: October 13-15, 2026 / Boise, ID CANCELLED COST: 3 Full Days for $2,400.00 (Fully transferable at any time.) Super Early Bird Pricing! First 10 registrations only $995 Deadline to claim: Aug 8th, 2026 Location: Albertsons Library, Boise State University campus (2nd...Read More
Company: Medtronic MiniMed, Inc. Date of Enforcement Report: 7/8/2026 Class: II PRODUCT: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 Recall Number: Z-2698-2026 REASON: A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump...Read More
Company: IPG Medical Corporation Date of Enforcement Report: 6/24/2026 Class: II PRODUCT: Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. Recall Number: Z-2554-2026 REASON: Software anomaly that causes a false display of error code 5018. RECALLING FIRM/MANUFACTURER: IPG Medical Corporation VOLUME: 198 units DISTRIBUTION: US Nationwide distribution in the state of MA.Read More
Company: Abiomed, Inc. Date of Enforcement Report: 6/12/2026 Class: I PRODUCT: Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU....Read More
Company: GE Medical Systems China Co., Ltd. Date of Enforcement Report: 6/3/2026 Class: II PRODUCT: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph Recall Number: Z-2306-2026 REASON: Software in development inadvertently made available for customer use. Use of this software version can result in clinical information...Read More
Company: Dexcom, Inc. Date of Enforcement Report: 5/11/2026 Class: II PRODUCT: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App – The watchOS app is installed along with the iOS phone app and...Read More
Company: Technological Medical Advancements LLC Date of Enforcement Report: 5/11/2026 Class: II PRODUCT Diowave Laser System, REF: Diowave 250W Recall Number: Z-2162-2026 REASON: Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local...Read More
Company: Beta Bionics, Inc. Date of Enforcement Report: 4/29/2026 Class: II PRODUCT: iLet Bionic Pancreas, REF: BB1001 Recall Number: Z-1996-2026 REASON: insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided,...Read More
Company: Boston Scientific Corporation Date of Enforcement Report: 4/24/2026 Class: I PRODUCT: Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker,...Read More
Company: Gentuity, LLC Date of Enforcement Report: 4/16/2026 Class: II PRODUCT: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; Recall Number: Z-1823-2026 REASON: The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to...Read More
Company: Philips Medical Systems Date of Enforcement Report: 4/16/2026 Class: II PRODUCT: Philips Spectral CT on Rails. Model Number: 728334 Recall Number: Z-1825-2026 REASON: Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2....Read More
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 4/10/2026 Class: II PRODUCT: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data. Recall Number: Z-1805-2026 REASON: Potential safety issue involving the Mean Aneurysm Flow Amplitude...Read More
Company: Medtronic MiniMed, Inc Date of Enforcement Report: 3/24/2026 Class: II PRODUCT: MiniMed” 780G – MMT-1884 MiniMed” 780G – MMT-1886 With Software 6.60 and 6.61 Recall Number: Z-1635-2026 REASON: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61,...Read More
Company: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Date of Enforcement Report: 2/20/2026 Class: II PRODUCT: Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR Recall Number: Z-1429-2026 REASON: Software anomaly in the patient positioning system may result in positional discrepancy. RECALLING FIRM/MANUFACTURER: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha VOLUME: 1 DISTRIBUTION: US distribution to states...Read More
Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 2/27/2026 Class: II PRODUCT: cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2...Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 2/3/2026 Class: II PRODUCT: SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS Recall Number: Z-1239-2026 REASON: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. RECALLING FIRM/MANUFACTURER: Siemens Medical Solutions USA, Inc...Read More
Company: Focalyx Technologies, LLC Date of Enforcement Report: 2/3/2026 Class: II PRODUCT: Focalyx Fusion Recall Number: Z-1243-2026 REASON: Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm...Read More
Company: Beckman Coulter, Inc Date of Enforcement Report: 2/2/2026 Class: II PRODUCT: CellMek SPS Sample Preparation System, REF: C44603, with software Recall Number: Z-1235-2026 REASON: Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid...Read More
Company: Intuitive Surgical, Inc Date of Enforcement Report: 2/2/2026 Class: II PRODUCT: Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three...Read More
