Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for...
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and M...
Z-0235-2014November 20, 2013Rochester, NY
Carestream Health Inc.
Class IITerminated
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for...
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and M...
Z-0249-2014November 20, 2013Rochester, NY
Carestream Health Inc.
Class IITerminated
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for...
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and M...
Z-0238-2014November 20, 2013Rochester, NY
Hospira Inc.
Class IITerminated
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Inf...
Reason: Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressu...
Z-0284-2014November 20, 2013Lake Forest, IL
Philips Healthcare Informatics, Inc.
Class IITerminated
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images an...
Reason: Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device ...
Z-0269-2014November 20, 2013Foster City, CA
Carestream Health Inc.
Class IITerminated
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pedi...
Reason: Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX ...
Z-0180-2014November 13, 2013Rochester, NY
Roche Diagnostics Operations, Inc.
Class IITerminated
COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling acces...
Reason: Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are rese...
Z-0168-2014November 13, 2013Indianapolis, IN
Carestream Health Inc.
Class IITerminated
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediat...
Reason: Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX ...
Z-0179-2014November 13, 2013Rochester, NY
Vital Images, Inc.
Class IITerminated
VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) sys...
Reason: Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapsh...
Z-0169-2014November 13, 2013Minnetonka, MN
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
Reason: Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination...
Z-0016-2014November 13, 2013Malvern, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produce...
Reason: Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical.
Z-0067-2014November 6, 2013Cleveland, OH
Carestream Health, Inc.
Class IITerminated
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is design...
Reason: During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX produ...
Z-0090-2014November 6, 2013Rochester, NY
AGFA Corp.
Class IITerminated
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Reason: System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
Z-0035-2014October 30, 2013Greenville, SC
Bio-Rad Laboratories
Class IIITerminated
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Reason: The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOL...
Z-0032-2014October 30, 2013Redmond, WA
Siemens Medical Solutions USA, Inc.
Class IITerminated
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging ...
Reason: Software issue results in inaccurate 3D image may result in ablation in wrong location.
Z-0052-2014October 30, 2013Mountain View, CA
GE Healthcare It
Class IITerminated
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose comput...
Reason: GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. M...
Z-0034-2014October 30, 2013Barrington, IL
Hologic, Inc.
Class IITerminated
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for scre...
Reason: Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Z-2301-2013October 9, 2013Danbury, CT
Mckesson Information Solutions LLC
Class IITerminated
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, ...
Reason: Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Z-2318-2013October 9, 2013Alpharetta, GA
GE Healthcare, LLC
Class IITerminated
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337...
Reason: GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and S...
Z-2266-2013October 2, 2013Waukesha, WI
GE Healthcare, LLC
Class IITerminated
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthca...
Reason: GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.
Z-2256-2013September 25, 2013Waukesha, WI
GE Healthcare, LLC
Class IITerminated
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Reason: GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
Z-2241-2013September 25, 2013Waukesha, WI
GE Healthcare, LLC
Class IITerminated
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Reason: GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management sof...
Z-2201-2013September 25, 2013Waukesha, WI
Copan Italia
Class IIITerminated
WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for...
Reason: The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The...
Z-2131-2013September 11, 2013Brescia, N/A
Nidek Inc
Class IITerminated
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
Reason: Under certain circumstances, the Left eye image may be saved as the Right eye image.
Z-2046-2013September 4, 2013Fremont, CA
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedure...
Reason: Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which requir...