BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): "...
Reason: Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used ...
Reason: The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
Z-2588-2023September 20, 2023Salt Lake City, UT
Diversatek Healthcare
Class IIIOngoing
ZVU Functional GI Software, REF: ZVU-3
Reason: GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Z-2521-2023September 13, 2023Highlands Ranch, CO
Stryker Corporation
Class IIOngoing
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during ...
Reason: Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Z-2463-2023September 6, 2023Portage, MI
RAYSEARCH LABORATORIES AB
Class IIOngoing
RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and trea...
Reason: An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expecte...
Z-2464-2023September 6, 2023Stockholm, N/A
Medtronic Neuromodulation
Class IIOngoing
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Reason: When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Mana...
Z-2226-2023August 2, 2023Minneapolis, MN
Hamilton Medical, Inc.
Class IOngoing
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Reason: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Z-2140-2023August 2, 2023Reno, NV
Hamilton Medical, Inc.
Class IOngoing
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Reason: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Z-2141-2023August 2, 2023Reno, NV
Hamilton Medical, Inc.
Class IOngoing
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Reason: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Z-2139-2023August 2, 2023Reno, NV
Hamilton Medical, Inc.
Class IOngoing
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Reason: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Reason: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient resul...
Reason: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient resul...
Reason: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an i...
Z-2103-2023July 19, 2023Deerfield, IL
Baxter Healthcare Corporation
Class IOngoing
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an i...
Z-2104-2023July 19, 2023Deerfield, IL
Siemens Healthcare Diagnostics, Inc.
Class IIOngoing
Aptio Automation Storage and Retrieval Module (SRM)
Reason: A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a d...
Reason: Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downti...
Z-2094-2023July 12, 2023San Diego, CA
Philips North America Llc
Class IIOngoing
DigitalDiagnost C90, Model No. 712034 and 712035
Reason: There is a software login in issue that may prevent the user from logging in.
Reason: A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra functio...
Reason: Cybersecurity vulnerability concerning the software used for sequencing instruments.
Z-1977-2023June 28, 2023San Diego, CA
SenTec AG
Class IIOngoing
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Reason: The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
Z-1980-2023June 28, 2023Therwil
Vyaire Medical
Class IICompleted
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Reason: Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unres...