Reason: Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hyp...
Z-1697-2025May 21, 2025Mettawa, IL
ICU Medical, Inc.
Class IIOngoing
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Reason: Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, p...
Reason: Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hyp...
Z-1698-2025May 21, 2025Mettawa, IL
Beckman Coulter Inc.
Class IIOngoing
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chem...
Reason: Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following sce...
Z-1784-2025May 21, 2025Brea, CA
Tornier S.A.S.
Class IIOngoing
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Reason: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Reason: Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at star...
Z-1729-2025May 14, 2025Farnborough, N/A
Philips Medical Systems Nederland B.V.
Class IIOngoing
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Reason: An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Z-1740-2025May 14, 2025Eindhoven, N/A
Leica Biosystems Melbourne Pty Ltd
Class IIOngoing
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tis...
Reason: There is a leakage issue associated with the tubing in the manifold of the instrument.
Z-1683-2025May 7, 2025Mount Waverley, N/A
Spectrum Medical Ltd.
Class IIOngoing
Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only d...
Reason: Medical device software marketed without FDA clearance .
Reason: The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
Z-1672-2025May 7, 2025Brea, CA
Siemens Healthcare Diagnostics Inc
Class IIOngoing
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & ...
Reason: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Z-1685-2025May 7, 2025Norwood, MA
Spectrum Medical Ltd.
Class IIOngoing
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is int...
Reason: Medical device software marketed without FDA clearance .
Z-1695-2025May 7, 2025Gloucester, N/A
Siemens Healthcare Diagnostics Inc
Class IIOngoing
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4...
Reason: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Z-1684-2025May 7, 2025Norwood, MA
Radiometer Medical ApS
Class IIOngoing
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automate...
Reason: ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sam...
Z-1659-2025April 30, 2025Bronshoj, N/A
Micro-X Ltd.
Class IIOngoing
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-conta...
Reason: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Z-1670-2025April 30, 2025Tonsley, N/A
Philips North America Llc
Class IIOngoing
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Reason: Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being ...
Z-1654-2025April 30, 2025Abbott Park, IL
Remote Diagnostic Technologies Ltd.
Class IIOngoing
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer)...
Reason: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being ...
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being ...
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being ...
Z-1655-2025April 30, 2025Abbott Park, IL
CareFusion 303, Inc.
Class IIOngoing
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; ...
Reason: Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 dest...
Z-1639-2025April 30, 2025San Diego, CA
Medtronic Xomed, Inc.
Class IIOngoing
NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIEN...
Reason: Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation...
Z-1623-2025April 30, 2025Jacksonville, FL
Micro-X Ltd.
Class IIOngoing
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a...
Reason: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being ...