epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitati...
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-0739-2025January 1, 2025East Walpole, MA
Becton, Dickinson and Company, BD Bio Sciences
Class IIOngoing
FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and...
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-...
Z-0747-2025January 1, 2025Milpitas, CA
Siemens Healthcare Diagnostics, Inc.
Class IIOngoing
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); 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-0737-2025January 1, 2025East Walpole, MA
Nova Biomedical Corporation
Class IOngoing
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Reason: A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management syst...
Z-0681-2025January 1, 2025Waltham, MA
SEASPINE ORTHOPEDICS CORPORATION
Class IIOngoing
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 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-0751-2025January 1, 2025Carlsbad, CA
Siemens Healthcare Diagnostics, Inc.
Class IIOngoing
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; 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-0741-2025January 1, 2025East Walpole, MA
Nova Biomedical Corporation
Class IOngoing
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. 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-0683-2025January 1, 2025Waltham, MA
Siemens Healthcare Diagnostics, Inc.
Class IIOngoing
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; 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-0738-2025January 1, 2025East Walpole, MA
Siemens Healthcare Diagnostics, Inc.
Class IIOngoing
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t...
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-0734-2025January 1, 2025East Walpole, MA
Abbott Medical
Class IIOngoing
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed ...
Reason: Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small...
Z-0753-2025January 1, 2025Sylmar, CA
Becton, Dickinson and Company, BD Bio Sciences
Class IIOngoing
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluo...
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-...
Z-0745-2025January 1, 2025Milpitas, CA
Siemens Healthcare Diagnostics, Inc.
Class IIOngoing
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; 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-0736-2025January 1, 2025East Walpole, MA
Becton, Dickinson and Company, BD Bio Sciences
Class IIOngoing
FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, an...
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-...
Z-0748-2025January 1, 2025Milpitas, CA
CooperSurgical, Inc.
Class IIOngoing
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming a...
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al...
Z-0688-2025December 25, 2024Trumbull, CT
Mint Medical GmbH
Class IIOngoing
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Reason: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Z-0709-2025December 25, 2024Dossenheim
CooperSurgical, Inc.
Class IIOngoing
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable w...
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al...
Z-0692-2025December 25, 2024Trumbull, CT
CooperSurgical, Inc.
Class IIOngoing
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming an...
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al...
Z-0689-2025December 25, 2024Trumbull, CT
CooperSurgical, Inc.
Class IIOngoing
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming an...
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al...
Z-0690-2025December 25, 2024Trumbull, CT
CooperSurgical, Inc.
Class IIOngoing
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or i...
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al...
Z-0691-2025December 25, 2024Trumbull, CT
Mint Medical GmbH
Class IIOngoing
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Reason: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Z-0710-2025December 25, 2024Dossenheim
Philips North America Llc
Class IIOngoing
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Reason: The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potent...
Z-0686-2025December 25, 2024Cambridge, MA
Hermes Medical Solutions AB
Class IIOngoing
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Reason: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Z-0678-2025December 18, 2024Stockholm
CareFusion 303, Inc.
Class IIOngoing
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
Reason: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) ...
Z-0671-2025December 18, 2024San Diego, CA
CareFusion 303, Inc.
Class IIOngoing
BD Pyxis MedStation ES, REF: 323
Reason: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) ...
Z-0670-2025December 18, 2024San Diego, CA
CareFusion 303, Inc.
Class IIOngoing
BD Pyxis CII Safe ES, REF: 1116-00
Reason: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) ...