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Carestream Health Recalls
86 recalls on record · August 22, 2012 to December 13, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intend
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intend
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intend
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image management system whose intended u
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image management system whose intended
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose inte
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose in
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intende
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image management system whose inte
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PACS is an image management system whose inte
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intend
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an image management system whose i
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM PACS is an image management system whose int
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an image management system whose in
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system whose intend
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 20, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose inten
Hazard: 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 MR may not load into the viewer application due to a software problem.
November 13, 2013Medical DevicesFDA
Carestream Health Inc. recalls CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Stre
Hazard: 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 Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure
November 13, 2013Medical DevicesFDA
Carestream Health Inc. recalls DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street
Hazard: 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 Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure
November 13, 2013Medical DevicesFDA
Carestream Health Inc. recalls DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty,
Hazard: Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.
November 6, 2013Medical DevicesFDA
Carestream Health, Inc. recalls Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
Hazard: Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.
November 6, 2013Medical DevicesFDA
Carestream Health, Inc. recalls DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415,
Hazard: 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 product console software is updated to v5.6b software and the detector is not calibrated before use.
August 21, 2013Medical DevicesFDA
Carestream Health Inc. recalls Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray
Hazard: Due to potential for an x-ray exposure technique change.
February 13, 2013Medical DevicesFDA
Carestream Health, Inc. recalls KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 811822
Hazard: Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a
August 22, 2012Medical DevicesFDA
Carestream Health, Inc. recalls Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St,
Hazard: Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.