Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B...
Reason: Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from ear...
Reason: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app...
Reason: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app...
Z-2164-2026May 20, 2026San Diego, CA
Technological Medical Advancements LLC
Class IIOngoing
Diowave Laser System, REF: Diowave 250W
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 arthri...
Reason: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app...
Z-2163-2026May 20, 2026San Diego, CA
Mint Medical GmbH
Class IIOngoing
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Reason: If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly li...
Z-2068-2026May 13, 2026Dossenheim
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical syst...
Reason: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Z-2046-2026May 13, 2026Sunnyvale, CA
Spacelabs Healthcare, Inc.
Class IIOngoing
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of t...
Reason: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
Z-2052-2026May 13, 2026Snoqualmie, WA
Hologic, Inc
Class IIOngoing
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes...
Reason: It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settin...
Z-1949-2026May 6, 2026Marlborough, MA
Boston Scientific Corporation
Class IOngoing
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U2...
Reason: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an...
Z-1771-2026May 6, 2026Saint Paul, MN
WHILL, INC.
Class IOngoing
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
Reason: Cyber vulnerability of BLE communication was found by CISA VDP program.
Z-1826-2026May 6, 2026Shinagawa
North American Rescue LLC.
Class IOngoing
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at th...
Reason: Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the ...
Z-1947-2026May 6, 2026Greer, SC
Advanced Bionics, LLC
Class IIOngoing
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-550...
Reason: The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell batter...
Z-1950-2026May 6, 2026Valencia, CA
Beta Bionics, Inc.
Class IIOngoing
iLet Bionic Pancreas, REF: BB1001
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, le...
Z-1996-2026May 6, 2026Irvine, CA
WHILL, INC.
Class IOngoing
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
Reason: Cyber vulnerability of BLE communication was found by CISA VDP program.
Z-1827-2026May 6, 2026Shinagawa
Boston Scientific Corporation
Class IOngoing
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 ...
Reason: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an...
Z-1770-2026May 6, 2026Saint Paul, MN
Zimmer, Inc.
Class IIOngoing
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Comp...
Reason: Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromise...
Reason: Software issue that renders the touch screen unresponsive.
Z-1828-2026April 29, 2026Princeton, NJ
Foundation Medicine, Inc.
Class IIOngoing
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990...
Reason: Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Z-1937-2026April 29, 2026Cambridge, MA
PHILIPS MEDICAL SYSTEMS
Class IIOngoing
Philips Spectral CT on Rails. Model Number: 728334.
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...
Z-1825-2026April 22, 2026Cambridge, MA
Gentuity, LLC
Class IIOngoing
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
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...