Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Reason: Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
Reason: Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
Z-0283-2024November 15, 2023Bothell, WA
Asensus Surgical Inc
Class ITerminated
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Nu...
Reason: Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparos...
Z-0170-2024November 8, 2023Durham, NC
Siemens Medical Solutions USA, Inc
Class IIOngoing
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110...
Reason: Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patien...
Z-0196-2024November 8, 2023Malvern, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Reason: Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patien...
Z-0195-2024November 8, 2023Malvern, PA
GE Healthcare
Class IIOngoing
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Reason: GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW...
Z-0140-2024November 1, 2023Chicago, IL
Acclarent, Inc.
Class IIOngoing
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Reason: When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during su...
Z-0127-2024November 1, 2023Irvine, CA
Impedimed Limited
Class IIOngoing
SOZO Bilateral Arm L-Dex Software
Reason: Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result ...
Z-0155-2024November 1, 2023Pinkenba, N/A
GE Healthcare
Class IIOngoing
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
Reason: GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW...
Z-0138-2024November 1, 2023Chicago, IL
OLEA MEDICAL
Class IIOngoing
Functional MR V1.0
Reason: When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause ...
Reason: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Z-0094-2024October 25, 2023Netanya, N/A
Smiths Medical ASD Inc.
Class IIOngoing
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, ...
Reason: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the forc...
Z-0079-2024October 18, 2023Minneapolis, MN
RoyalVibe Health Ltd.
Class IIOngoing
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
Reason: Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of cust...
Z-0082-2024October 18, 2023The Woodlands, TX
Smiths Medical ASD Inc.
Class IIOngoing
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
Reason: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the forc...
Z-0078-2024October 18, 2023Minneapolis, MN
Mazor Robotics Ltd
Class IIOngoing
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Reason: Software update
Z-0101-2024October 18, 2023Caesarea, N/A
Blue Belt Technologies, Inc
Class IIOngoing
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Reason: CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon choo...
Z-0041-2024October 11, 2023Pittsburgh, PA
Medtronic Neuromodulation
Class IITerminated
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Reason: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulti...
Reason: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Z-2655-2023October 11, 2023Cambridge, MA
Philips Healthcare
Class IIOngoing
Incisive CT, software version 5.0
Reason: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the opti...
Z-2520-2023October 11, 2023Cambridge, MA
Fresenius Kabi USA, LLC
Class IIOngoing
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled ad...
Reason: Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment w...
Z-2635-2023October 4, 2023North Andover, MA
CareFusion 303, Inc.
Class IIOngoing
BD Pyxis MedBank MedPass Software, REF: 139088-01
Reason: After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for ...
Z-2646-2023October 4, 2023San Diego, CA
Baxter Healthcare Corporation
Class IIOngoing
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Reason: Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of th...
Z-2647-2023October 4, 2023Deerfield, IL
Exocad GmbH
Class IIOngoing
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents...
Reason: A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a gui...
Z-2633-2023October 4, 2023Darmstadt, N/A
Philips North America Llc
Class IIOngoing
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number...
Reason: Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardw...