The Recall Desk

Manufacturer

Carestream Health, Inc.

86 recalls in our database name Carestream Health, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
86
Critical
0
Severe
3
Most recent
2023-12-13

Of the 86 recalls from Carestream Health, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–86 of 86

  • ModerateFDA (Devices)·Z-0228-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading into the viewer under specific conditions.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC ADD 10K 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 hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0240-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software due to a defect that may prevent some CT and MR images from loading in the viewer.

    Product
    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 provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0225-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    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 provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0132-2014·2013-11-13

    Carestream DRX Revolution Mobile X-Ray System Column Cover Recall

    Carestream Health is recalling DRX Revolution mobile x-ray systems because the column end cover may dislodge from the column.

    Product
    DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2014·2013-11-13

    Carestream DRX Mobile X-Ray Systems Recalled for Software Defect

    Carestream Health is voluntarily patching DRX Mobile X-Ray systems to fix a software issue causing non-diagnostic images.

    Product
    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 pediatric and adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0179-2014·2013-11-13

    Carestream DRX-Revolution Mobile X-Ray Systems Software Patch Recall

    Carestream Health is voluntarily installing a software patch on DRX-Revolution mobile X-ray systems to address reports of non-diagnostic images during normal exposure exams.

    Product
    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 pediatric and adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0126-2014·2013-11-06

    Carestream DRX-Revolution Mobile X-ray System Recalled for Sparking Power Plug

    Carestream Health is recalling 180 DRX-Revolution Mobile X-ray Systems because the power plug generates sparks and becomes warm to the touch.

    Product
    Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0090-2014·2013-11-06

    Carestream DRX Revolution Mobile X-Ray System Recalled for Image Artifacts

    Carestream Health is recalling 23 DRX Revolution Mobile X-Ray Systems because a software update without detector calibration can cause image artifacts.

    Product
    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 designed to perform radiographic x-ray examinations on all pediatric and adult patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2013·2013-08-21

    Carestream DRX Evolution X-Ray System Recalled for Exposure Technique Change

    Carestream Health is recalling DRX Evolution X-Ray systems due to a potential change in x-ray exposure technique.

    Product
    Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0744-2013·2013-02-13

    Carestream Recalls Dental Film Due to Missing Label Symbols

    Carestream Health is recalling specific lots of Kodak Insight Dental Film because the clear carton labels are missing required symbols and manufacturer information.

    Product
    KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2012·2012-08-22

    Carestream DRX-1 System Battery Recall for Overheating Risk

    Carestream Health is recalling DRX-1 system batteries manufactured before June 2012 due to two reported instances of lithium-ion battery overheating that may cause burns.

    Product
    Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Carestream Health

American medical imaging company

Country
United States
Founded
2007

Official website

Source: Wikidata (Q5039058), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.