Carestream Health, Inc.
Rochester, NY
This page shows every FDA and USDA recall linked to Carestream Health, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
87
Total Recalls
2007
First Recall
2023
Most Recent
DRX Revolution Mobile X-Ray System
Dec 1, 2023
· Device
Open, Classified
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR)...
Nov 9, 2023
· Device
Open, Classified
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quali...
Mar 2, 2023
· Device
Open, Classified
Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generat...
Jan 6, 2020
· Device
Terminated
OnSight 3D Extremity System- X-Ray, Tomography Computed System
Catalog Numbers:
1743566 (w/ Attached Console)...
Mar 19, 2019
· Device
Terminated
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177...
Jun 19, 2017
· Device
Terminated
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System
Diagnostic...
Jan 19, 2017
· Device
Terminated
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalo...
Jan 12, 2017
· Device
Terminated
Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Com...
Jul 18, 2016
· Device
Terminated
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: RE...
May 2, 2016
· Device
Terminated
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE...
May 2, 2016
· Device
Terminated
CARESTREAM DRX-EVOLUTION X-Ray System
Product Usage:
The device is a permanently installed diagnostic X-ray...
Aug 22, 2015
· Device
Terminated
CS 8100 3D, CATALOG # (s): 5311162, 5311188.
Intended to produce complete or segmented tomographic digital pa...
Apr 3, 2015
· Device
Terminated
CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110
Intended to produce complete or segmented tomograp...
Apr 3, 2015
· Device
Terminated
CARESTREAM DIRECTVIEW CR Software
Generates digital mammographic images that can be used for screening and di...
Dec 17, 2014
· Device
Terminated
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 101939...
Dec 16, 2014
· Device
Terminated
Kodak DirectView DR 7500 Diagnostic X-Ray System
Product Usage: The DR 7500 system is a permanently install...
Aug 10, 2014
· Device
Terminated
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc...
Aug 1, 2014
· Device
Terminated
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Cana...
Aug 1, 2014
· Device
Terminated
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health...
Aug 1, 2014
· Device
Terminated
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream H...
Mar 4, 2014
· Device
Terminated
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Veron...
Mar 4, 2014
· Device
Terminated
Carestream DRX Evolution System (Standard Q)
The DRX-Evolution System (Standard Q) is a permanently installed...
Jan 29, 2014
· Device
Terminated
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, R...
Jan 3, 2014
· Device
Terminated
Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; Virtual Reading Basic SW StandAlone
The CARESTREAM PACS is an image management system wh...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whos...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone
The CARESTREAM PACS is an image management system wh...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE
The CARESTREAM PACS is an image management system whose in...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR
The CARESTREAM PACS is an image management system whose...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR
The CARESTREAM PACS is an image management system whose...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whos...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; Virtual Enterprise SW StandAlone
The CARESTREAM PACS is an image management system whose...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW
The CARESTREAM PACS is an image management system whose...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whos...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR
The CARESTREAM PACS is an image management system whose...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; Virtual Access Plus SW, Workgroup
The CARESTREAM PACS is an image management system whos...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack
The CARESTREAM PACS is an image management system w...
Nov 13, 2013
· Device
Terminated
Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR
The CARESTREAM PACS is an image management system who...
Nov 13, 2013
· Device
Terminated