Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Produ...
Reason: The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This cou...
Reason: Potential for hole in package compromising sterility of the medical kit.
Z-1014-2025January 29, 2025Salisbury, MD
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N542...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0999-2025January 29, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Reason: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Z-0983-2025January 29, 2025Mechanicsville, VA
Ortho-Clinical Diagnostics, INc.
Class IIOngoing
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher ...
Reason: The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. Th...
Z-1007-2025January 29, 2025Rochester, NY
A L I Technologies Ltd
Class IIOngoing
McKesson Cardiology Hemo software
Reason: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Reason: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Z-0901-2025January 22, 2025Rochester, NY
CareFusion 303, Inc.
Class IIOngoing
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Reason: Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combinati...
Z-0906-2025January 22, 2025San Diego, CA
A L I Technologies Ltd
Class IIOngoing
Change Healthcare Cardiology Hemo software
Reason: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Reason: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Z-0959-2025January 22, 2025Burnaby
GE Medical Systems, LLC
Class IIOngoing
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facil...
Reason: There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
Z-0918-2025January 22, 2025Waukesha, WI
Spacelabs Healthcare, Inc.
Class IIOngoing
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Reason: Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will ...
Z-0810-2025January 15, 2025Snoqualmie, WA
Medtronic Neuromodulation
Class IIOngoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
Reason: Software issues were identified in application version 2.x.
Z-0771-2025January 8, 2025Minneapolis, MN
Medtronic Neuromodulation
Class IIOngoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Reason: Software issues were identified in application version 2.x.
Z-0772-2025January 8, 2025Minneapolis, MN
Medtronic Neuromodulation
Class IIOngoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
Reason: Software issues were identified in application version 2.x.
Z-0773-2025January 8, 2025Minneapolis, MN
Medtronic Neuromodulation
Class IIOngoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, C...
Reason: Software issues were identified in application version 2.x.
Z-0774-2025January 8, 2025Minneapolis, MN
Siemens Healthcare Diagnostics, Inc.
Class IIOngoing
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative...
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the inc...
Z-0735-2025January 1, 2025East Walpole, MA
SEASPINE ORTHOPEDICS CORPORATION
Class IIOngoing
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
Reason: Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Z-0752-2025January 1, 2025Carlsbad, CA
Nova Biomedical Corporation
Class IOngoing
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Reason: A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at...
Z-0682-2025January 1, 2025Waltham, MA
Siemens Healthcare Diagnostics, Inc.
Class IIOngoing
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantita...
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the inc...
Z-0740-2025January 1, 2025East Walpole, MA
Braemar Manufacturing, LLC
Class IOngoing
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Reason: Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring se...
Z-0708-2025January 1, 2025San Diego, CA
Becton, Dickinson and Company, BD Bio Sciences
Class IIOngoing
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3...
Reason: On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-...