Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Z-2729-2015September 9, 2015Ithaca, NY
Transonic Systems Inc
Class IITerminated
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Reason: Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. If the user is utilizing User- Configured (Modified)...
Z-2544-2015September 9, 2015Rochester, NY
Intuitive Surgical, Inc.
Class IITerminated
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, M...
Reason: Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
Z-2734-2015September 9, 2015Sunnyvale, CA
Transonic Systems Inc
Class IITerminated
Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Z-2725-2015September 9, 2015Ithaca, NY
Transonic Systems Inc
Class IITerminated
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Z-2727-2015September 9, 2015Ithaca, NY
Transonic Systems Inc
Class IITerminated
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Z-2723-2015September 9, 2015Ithaca, NY
Transonic Systems Inc
Class IITerminated
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Z-2726-2015September 9, 2015Ithaca, NY
Transonic Systems Inc
Class IITerminated
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Z-2720-2015September 9, 2015Ithaca, NY
Transonic Systems Inc
Class IITerminated
Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Z-2724-2015September 9, 2015Ithaca, NY
Transonic Systems Inc
Class IITerminated
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Z-2728-2015September 9, 2015Ithaca, NY
Transonic Systems Inc
Class IITerminated
Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
Reason: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met...
Z-2721-2015September 9, 2015Ithaca, NY
GE Healthcare
Class IITerminated
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabiliti...
Reason: Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
Z-2469-2015September 2, 2015Barrington, IL
Carestream Health Inc
Class IITerminated
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feat...
Reason: Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetec...
Reason: Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations.
Z-2477-2015September 2, 2015Fremont, CA
GE Healthcare
Class IITerminated
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities re...
Reason: Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
Z-2470-2015September 2, 2015Barrington, IL
Getinge Disinfection Ab
Class IIITerminated
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, a...
Reason: Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
Z-2419-2015August 26, 2015Vaxjo
BIOTRONIK, Inc.
Class IITerminated
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). All...
Reason: Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
Z-2376-2015August 19, 2015Lake Oswego, OR
Philips Electronics North America Corporation
Class IITerminated
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and q...
Reason: Multiple software and hardware issues with device that can affect its function.
Z-2328-2015August 12, 2015Andover, MA
Siemens Medical Solutions USA, Inc.
Class IITerminated
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S ...
Reason: Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagno...
Z-2314-2015August 5, 2015Mountain View, CA
Hamilton Medical, Inc.
Class IITerminated
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infa...
Reason: Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the devic...
Z-2057-2015August 5, 2015Reno, NV
Volcano Corporation
Class IITerminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/...
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Z-2133-2015July 29, 2015Rancho Cordova, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suita...
Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased t...
Z-2195-2015July 29, 2015Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for ...
Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased t...
Z-2194-2015July 29, 2015Cleveland, OH
Philips Electronics North America Corporation
Class IITerminated
Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, ...
Reason: Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of ...