A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
Reason: A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification fe...
Z-0883-2021January 27, 2021Indianapolis, IN
Fujifilm Medical Systems U.S.A., Inc.
Class IIOngoing
Synapse PACS Software Versions 5.1 and higher
Reason: There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT stu...
Z-0878-2021January 27, 2021Lexington, MA
Philips Ultrasound Inc
Class IITerminated
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD -...
Reason: The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest dif...
Z-0864-2021January 20, 2021Bothell, WA
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis o...
Reason: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Z-0863-2021January 20, 2021Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis o...
Reason: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Z-0862-2021January 20, 2021Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of...
Reason: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Z-0861-2021January 20, 2021Tarrytown, NY
Roche Molecular Systems, Inc.
Class IITerminated
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro di...
Reason: Dirty Lens May Cause Invalid or False Positive Results
Z-0846-2021January 20, 2021Branchburg, NJ
Medtronic Inc.
Class IIOngoing
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
Reason: Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at...
Z-0843-2021January 20, 2021Northridge, CA
Philips North America, LLC
Class IITerminated
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Reason: A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Z-0852-2021January 20, 2021Andover, MA
Medtronic Neuromodulation
Class IIOngoing
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtron...
Reason: A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Z-0860-2021January 20, 2021Minneapolis, MN
ICU Medical, Inc.
Class IITerminated
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diag...
Reason: Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
Z-0859-2021January 20, 2021San Clemente, CA
Ortho-Clinical Diagnostics, Inc.
Class IITerminated
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, ...
Reason: A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lea...
Z-0800-2021January 13, 2021Rochester, NY
Ortho-Clinical Diagnostics, Inc.
Class IITerminated
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
Reason: A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lea...
Z-0801-2021January 13, 2021Rochester, NY
Baxter Healthcare Corporation
Class IIOngoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
Reason: There is a potential software error during programming.
Z-0714-2021December 30, 2020Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Reason: There is a potential software error during programming.
Z-0712-2021December 30, 2020Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Reason: There is a potential software error during programming.
Z-0713-2021December 30, 2020Deerfield, IL
Haag-Streit USA Inc
Class IIOngoing
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no....
Reason: Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not ...
Z-0697-2021December 30, 2020Mason, OH
Baxter Healthcare Corporation
Class IIOngoing
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
Reason: There is a potential software error during programming.
Z-0715-2021December 30, 2020Deerfield, IL
Kowa Optimed Inc
Class IITerminated
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s...
Reason: It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a ...
Z-0636-2021December 23, 2020Torrance, CA
Remote Diagnostic Technologies Ltd.
Class IITerminated
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and...
Reason: A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out ...
Z-0564-2021December 23, 2020Basingstoke, N/A
Medtronic Neuromodulation
Class IITerminated
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease,...
Reason: A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Z-0612-2021December 23, 2020Minneapolis, MN
Shimadzu Medical Systems
Class IIOngoing
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and i...
Reason: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after ...
Z-0554-2021December 16, 2020Torrance, CA
Shimadzu Medical Systems
Class IIOngoing
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational...
Reason: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after ...
Z-0556-2021December 16, 2020Torrance, CA
Shimadzu Medical Systems
Class IIOngoing
Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography,...
Reason: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after ...
Z-0555-2021December 16, 2020Torrance, CA
Canon Medical System, USA, INC.
Class IITerminated
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
Reason: A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This ...