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All Recalls

Every Software Defect Recall

Sorted by most recent. Click any recall for full details and safety information.

1,491 recalls
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower Us...
Diagnostic Devices·2,038 affected·Oct 7, 2013
High RiskFDA
Lap Of America Laser Applications, Llc
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient a...
Medical Devices·280 affected·Oct 7, 2013
High RiskFDA
Toshiba American Medical Systems Inc
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion ...
Medical Devices·338 affected·Oct 1, 2013
High RiskFDA
Midmark Corp Dba Progeny Inc
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, includin...
Medical Implants·58 affected·Sep 20, 2013
High RiskFDA
Agfa Corp.
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Medical Devices·4 affected·Sep 19, 2013
High RiskFDA
Ge Healthcare, Llc
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advanta...
Diagnostic Devices·1,458 affected·Sep 19, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide ...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
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 prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provid...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provid...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image management system whose intended use is to pr...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provid...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to ...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
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 prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image management system whose intended use is to pro...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
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 prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide c...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to pro...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provid...
Medical Devices·1,131 affected·Sep 11, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein me...
Diagnostic Devices·892 affected·Sep 3, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensif...
Medical Devices·357 affected·Sep 3, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein me...
Diagnostic Devices·625 affected·Sep 3, 2013
High RiskFDA
Carestream Health Inc.
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY ...
Medical Devices·364 affected·Aug 29, 2013
High RiskFDA
Carestream Health Inc.
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14...
Medical Devices·190 affected·Aug 29, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified ...
Medical Devices·76 affected·Aug 28, 2013
High RiskFDA
Ge Healthcare It
Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation ...
Medical Implants·28 affected·Aug 26, 2013
RecallFDA
Bio-rad Laboratories
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Medical Devices·23 affected·Aug 20, 2013