Brand

Carestream Health Inc. Recalls

58 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Carestream Health Inc..

58Total Recalls
2Critical
24,486Units Affected
Oct 2, 2023Most Recent
All Recalls

Every Carestream Health Inc. Recall

Sorted by most recent. Click any recall for full details.

58 recalls
High RiskFDA
Carestream Health, Inc.
DRX Revolution Mobile X-Ray System
Medical Devices·3,961 affected·Oct 2, 2023
CriticalFDA
Carestream Health, Inc.
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system cons...
Diagnostic Devices·2,402 affected·Oct 2, 2023
High RiskFDA
Carestream Health, Inc.
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to a...
Diagnostic Devices·72 affected·Jan 30, 2023
High RiskFDA
Carestream Health, Inc.
Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for ex...
Diagnostic Devices·79 affected·Jan 6, 2020
High RiskFDA
Carestream Health, Inc.
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Conso...
Medical Devices·37 affected·Mar 19, 2019
High RiskFDA
Carestream Health Inc
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) ...
Medical Devices·1,403 affected·Jan 12, 2017
High RiskFDA
Carestream Health Inc
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or flu...
Diagnostic Devices·14 affected·Nov 21, 2016
High RiskFDA
Carestream Health Inc
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 65...
Medical Devices·37 affected·Apr 15, 2016
High RiskFDA
Carestream Health Inc
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radio...
Diagnostic Devices·76 affected·Aug 7, 2015
High RiskFDA
Carestream Health Inc
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) ---...
Diagnostic Devices·629 affected·Nov 25, 2014
High RiskFDA
Carestream Health, Inc.
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Medical Devices·59 affected·Oct 30, 2014
RecallFDA
Carestream Health Inc.
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Medical Devices·1,633 affected·Jul 2, 2014
RecallFDA
Carestream Health Inc.
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Medical Devices·1,633 affected·Jul 2, 2014
High RiskFDA
Carestream Health Inc.
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently inst...
Diagnostic Devices·100 affected·May 30, 2014
High RiskFDA
Carestream Health Inc.
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 1460...
Diagnostic Devices·347 affected·Jan 24, 2014
High RiskFDA
Carestream Health Inc.
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France ...
Diagnostic Devices·347 affected·Jan 24, 2014
High RiskFDA
Carestream Health, Inc.
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator consol...
Diagnostic Devices·493 affected·Nov 25, 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