Reason: Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, an...
Z-1742-2022September 21, 2022San Carlos, CA
FUJIFILM Healthcare Americas Corporation
Class IIOngoing
Surpria: Software Version V3.11, V3.22
Reason: Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in t...
Z-1749-2022September 21, 2022Lexington, MA
FUJIFILM Healthcare Americas Corporation
Class IIOngoing
Surpria 64: Software Version V3.11, V3.22
Reason: Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in t...
Z-1750-2022September 21, 2022Lexington, MA
FUJIFILM Healthcare Americas Corporation
Class IIOngoing
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Reason: Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in t...
Z-1748-2022September 21, 2022Lexington, MA
Boston Scientific Corporation
Class IIOngoing
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functi...
Reason: There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain ...
Z-1671-2022September 7, 2022Saint Paul, MN
Aggredyne, Inc.
Class IICompleted
AggreGuide A-100 Instrument
Reason: The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to t...
Reason: There are 7 reported software anomalies that may affect use of the device.
Z-1640-2022September 7, 2022Durham, NC
Boston Scientific Corporation
Class IIOngoing
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use con...
Reason: There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain ...
Z-1669-2022September 7, 2022Saint Paul, MN
Oculus Optikgeraete GMBH
Class IIOngoing
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Reason: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Z-1672-2022September 7, 2022Wetzlar
Oculus Optikgeraete GMBH
Class IIOngoing
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Reason: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Z-1674-2022September 7, 2022Wetzlar
Oculus Optikgeraete GMBH
Class IIOngoing
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Reason: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Z-1673-2022September 7, 2022Wetzlar
Boston Scientific Corporation
Class IIOngoing
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functi...
Reason: There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain ...
Z-1670-2022September 7, 2022Saint Paul, MN
Aesculap Implant Systems LLC
Class IITerminated
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Reason: Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
Z-1516-2022August 17, 2022Center Valley, PA
Spacelabs Healthcare, Inc.
Class IIOngoing
Xhibit Telemetry Receiver, Model: 96280
Reason: Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low ...
Z-1513-2022August 17, 2022Snoqualmie, WA
Roche Diagnostics Operations, Inc.
Class IIOngoing
cobas e801 Immunoassay Analyzer
Reason: Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IG...
Z-1515-2022August 17, 2022Indianapolis, IN
St. Jude Medical, Cardiac Rhythm Management Division
Class IIOngoing
Merlin PCS 3650 programmer Model 3330 software
Reason: There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain p...
Z-1495-2022August 10, 2022Sylmar, CA
St. Jude Medical, Cardiac Rhythm Management Division
Class IIOngoing
Merlin.net model MN5000 Software
Reason: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devic...
Z-1497-2022August 10, 2022Sylmar, CA
St. Jude Medical, Cardiac Rhythm Management Division
Class IIOngoing
Merlin 2 PCS MER37000 programmer Model MER3400 software
Reason: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devic...
Reason: The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.6...
Reason: There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
Z-1376-2022August 3, 2022Deerfield, IL
NordicNeuroLab AS
Class IITerminated
nordicBrainEX, software versions 2.21 through 2.3.10
Reason: When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output m...
Z-1462-2022August 3, 2022Bergen
GE Healthcare, LLC
Class IITerminated
Centricity PACS Software Version 7.0 SP0.0.4.7
Reason: The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
Z-1466-2022August 3, 2022Waukesha, WI
Siemens Medical Solutions USA, Inc
Class IIOngoing
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology M...
Reason: Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivit...
Z-1425-2022July 27, 2022Malvern, PA
Stryker Instruments Div. of Stryker Corporation
Class IIITerminated
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Reason: Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
Z-1394-2022July 27, 2022Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class IITerminated
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during su...
Reason: When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close....