A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* ...
Reason: There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (...
Z-1368-2021April 14, 2021Minneapolis, MN
Fujifilm Medical Systems U.S.A., Inc.
Class IIOngoing
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with...
Reason: The wrong patient information may be displayed in the viewer or PowerJacket.
Z-1348-2021April 14, 2021Lexington, MA
Biocare Medical, LLC
Class IITerminated
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Reason: Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could re...
Z-1333-2021April 7, 2021Pacheco, CA
CAIRE DIAGNOSTICS INC
Class IITerminated
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in cri...
Reason: Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readi...
Z-1284-2021March 31, 2021Pleasanton, CA
Biomerieux Inc
Class IITerminated
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). V...
Reason: bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, t...
Z-1308-2021March 31, 2021Hazelwood, MO
Biomerieux Inc
Class IITerminated
VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 i...
Reason: bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, t...
Z-1307-2021March 31, 2021Hazelwood, MO
Hitachi Medical Systems America Inc
Class IITerminated
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operativ...
Reason: Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE func...
Z-1282-2021March 31, 2021Twinsburg, OH
Mindray DS USA, Inc. dba Mindray North America
Class IIOngoing
Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.0...
Reason: BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no ...
Z-1254-2021March 24, 2021Mahwah, NJ
Siemens Medical Solutions USA, Inc
Class IITerminated
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All ...
Reason: SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user noti...
Reason: In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined toleranc...
Z-1185-2021March 17, 2021Munich
Thermo Fisher Scientific
Class IITerminated
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Reason: Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in ...
Z-1202-2021March 17, 2021Vantaa
Siemens Medical Solutions USA, Inc
Class IITerminated
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies...
Reason: System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Z-1173-2021March 10, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional proced...
Reason: Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include Sys...
Z-1144-2021March 3, 2021Malvern, PA
Carl Zeiss Meditec AG
Class IITerminated
IOLMaster 700
Reason: When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the p...
Z-1133-2021February 24, 2021Jena, N/A
Brainreader ApS
Class IITerminated
Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures iden...
Reason: The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Z-0934-2021February 10, 2021Horsens
Biomeme, Inc.
Class IIITerminated
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Fr...
Reason: Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results ...
Z-0940-2021February 10, 2021Philadelphia, PA
Fujifilm Medical Systems U.S.A., Inc.
Class IITerminated
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is netwo...
Reason: The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
Z-0918-2021February 3, 2021Lexington, MA
Roche Molecular Systems, Inc.
Class IITerminated
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Reason: When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "S...