Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as wel...
Reason: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possib...
Z-2441-2024July 31, 2024Malvern, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizati...
Reason: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possib...
Z-2439-2024July 31, 2024Malvern, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic cathet...
Reason: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possib...
Z-2440-2024July 31, 2024Malvern, PA
Alcon Research LLC
Class IIOngoing
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Reason: After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registrat...
Reason: If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the produ...
Z-2374-2024July 24, 2024San Diego, CA
Qiagen Sciences LLC
Class IIOngoing
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900...
Reason: Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304)...
Z-2353-2024July 24, 2024Germantown, MD
Echonous Inc
Class IIOngoing
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Reason: Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other...
Reason: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Reason: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Reason: Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination o...
Z-2264-2024July 10, 2024Chaska, MN
CareFusion 303, Inc.
Class IIOngoing
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Reason: Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
Reason: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Z-2248-2024July 10, 2024Blue Ash, OH
Siemens Healthcare Diagnostics Inc
Class IIOngoing
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11...
Reason: Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the c...
Z-2214-2024July 3, 2024Norwood, MA
Blue Belt Technologies, Inc
Class IIOngoing
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anat...
Reason: CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical ...
Z-2135-2024June 19, 2024Pittsburgh, PA
WAVi Co.
Class IIOngoing
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporat...
Reason: Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Reason: Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.
Reason: Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.
Z-2022-2024June 12, 2024Bothell, WA
Nihon Kohden America Inc
Class IIOngoing
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital sig...
Reason: Due to software issue the device may give false "SpO2 Probe Failure" alarm
Reason: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Z-1925-2024June 5, 2024Fort Worth, TX
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
Reason: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table...
Z-1896-2024June 5, 2024Best
Stryker Orthopaedics
Class IIOngoing
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+P...
Reason: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when ...
Z-1912-2024June 5, 2024Montclair, NJ
Stryker Orthopaedics
Class IIOngoing
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+P...
Reason: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when ...
Z-1914-2024June 5, 2024Montclair, NJ
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Reason: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table...