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.

1–25 of 86

  • HighFDA (Devices)·Z-0437-2024·2023-12-13

    DRX Revolution Mobile X-Ray System Electrical Component Failure Recall

    Carestream Health is recalling the DRX Revolution Mobile X-Ray System due to unexpected failure of electrical components in the CPI generator. The recall affects approximately 3,961 units distributed worldwide.

    Product
    DRX Revolution Mobile X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2024·2023-11-15

    DRX-Revolution Mobile X-Ray System Generator May Overheat Unexpectedly

    Carestream Health is recalling 2,402 DRX-Revolution Mobile X-Ray Systems due to potential electrical failure in the generator causing thermal overload. The system becomes inoperable and may produce loud noise, burnt smell, and smoke.

    Product
    The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of st
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2023·2023-03-08

    X-ray System Overhead Crane May Continue Moving Unexpectedly

    Carestream Health is recalling certain DRX-Compass/DR-FIT X-ray systems because the overhead tube crane may unexpectedly continue moving after Z-axis motorized buttons are pressed and released, potentially causing injury.

    Product
    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 aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2020·2020-01-22

    Carestream Recalls Kodak DirectView DR3000/3500 X-Ray Systems for U-Arm Movement

    Carestream Health is recalling 79 Kodak DirectView DR3000/3500 diagnostic x-ray systems due to a potential safety issue involving unintended movement of the U-Arm.

    Product
    Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky ass
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1207-2019·2019-05-01

    Carestream OnSight 3D Extremity System Recalled for Software Data Error

    Carestream Health is recalling 37 OnSight 3D Extremity Systems because a software error may leave companion imaging volumes in the original patient's exam during re-assignment.

    Product
    OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2017·2017-07-05

    Carestream Recalls DRX-Revolution Mobile X-Ray Systems Due to Assembly Defect

    Carestream Health Inc is recalling DRX-Revolution Mobile X-Ray Systems because missing screws could cause the tube and yoke assembly to separate.

    Product
    DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1138-2017·2017-02-15

    Carestream DRX-Revolution Mobile X-Ray System Recalled for Brake Failure

    Carestream Health is recalling DRX-Revolution Mobile X-Ray Systems because a complaint alleged the unit could not be stopped when applying the brake, resulting in a crash into an elevator.

    Product
    Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1052-2017·2017-01-25

    Carestream Ultrasound Systems Recalled for Software Measurement Unit Error

    Carestream Health Inc. is recalling Touch Prime and Touch Prime XE ultrasound systems due to a software error that may display incorrect measurement units.

    Product
    Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2217-2016·2016-07-27

    Carestream Touch Ultrasound Recalled for Volume Measurement Software Error

    Carestream Health is recalling Touch Prime and Touch Prime XE ultrasound units because a software issue may cause anatomy volume measurements to be overestimated.

    Product
    Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1594-2016·2016-05-11

    Carestream Image Suite V4 Recalled for Incorrect Image Annotation Display

    Carestream Health is recalling Image Suite V4 systems because a complaint reported that image annotations displayed 'L (Left)' instead of 'R (Right)'.

    Product
    CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1593-2016·2016-05-11

    Carestream Image Suite V3 Recalled for Incorrect Image Annotation

    Carestream Health is recalling Image Suite V3 units due to a software error that displays incorrect left/right image annotations.

    Product
    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Hea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2449-2015·2015-09-02

    Carestream DRX-Evolution X-Ray System Recalled for Image Stitching Defect

    Carestream Health is recalling DRX-Evolution X-ray systems due to a software defect that may cause undetected image stitching inconsistencies.

    Product
    CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1377-2015·2015-04-15

    Carestream CS 8100 X-ray Device Recalled for Unexpected Head Descent

    Carestream Health is recalling CS 8100 panoramic X-ray units because the device head may descend unexpectedly. Approximately 3,110 units were distributed worldwide.

    Product
    CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1378-2015·2015-04-15

    Carestream CS 8100 3D Dental X-Ray Devices Recalled for Unexpected Head Descent

    Carestream Health is recalling 470 CS 8100 3D dental X-ray units because the device head may descend unexpectedly, posing a risk of injury to patients or operators.

    Product
    CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic su
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0800-2015·2014-12-24

    Carestream DRX-Revolution Mobile X-Ray System Recalled for Broken Bolts

    Carestream Health is recalling 629 DRX-Revolution Mobile X-Ray Systems because bolts securing the x-ray tube assembly may break, posing a risk of equipment failure.

    Product
    DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0820-2015·2014-12-24

    Carestream DirectView CR Software Recalled for Reduced Mammographic Image Quality

    Carestream Health is recalling 59 units of DirectView CR Software due to reduced image quality when printing true size multi-format images.

    Product
    CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2177-2014·2014-08-20

    Carestream Recalls Kodak DirectView DR 7500 X-Ray Systems Due to Loose Parts

    Carestream Health is recalling 589 Kodak DirectView DR 7500 diagnostic x-ray systems because the x-ray tube assembly may detach from the overhead crane due to insufficiently tightened hardware.

    Product
    Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2014·2014-08-13

    Carestream KODAK DirectView DR 9000 X-Ray System Recalled for Control Failure

    Carestream Health is recalling KODAK DirectView DR 9000 systems because a control failure may cause the U-Arm to move downward unexpectedly at three times the normal speed.

    Product
    KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2142-2014·2014-08-13

    Carestream Recalls INSIGHT Dental Film Due to Indicator Dot Misplacement

    Carestream Health Inc. is recalling INSIGHT Dental Film because the indicator dot on the packaging is misaligned, which may cause dental practitioners to view images upside down.

    Product
    INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2143-2014·2014-08-13

    Carestream Recalls Ultra-speed Dental Film Due to Indicator Dot Misalignment

    Carestream Health Inc. is recalling 1,633 boxes of Ultra-speed Dental Film because the indicator dot is incorrectly positioned, which may cause image orientation errors.

    Product
    Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1127-2014·2014-03-12

    Carestream Recalls Kodak 2100 Intraoral X-Ray Systems Due to Arm Breakage

    Carestream Health is recalling Kodak 2100 Intraoral X-Ray Systems because the device arms may break early. The recall covers 347 units distributed in the US and Canada.

    Product
    Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2014·2014-03-12

    Carestream Recalls Kodak 2200 Intraoral X-Ray Systems Due to Arm Failure

    Carestream Health is recalling Kodak 2200 Intraoral X-Ray Systems because the device arms may break early. This affects 347 units distributed in the US and Canada.

    Product
    Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major componen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2014·2014-02-05

    Carestream DRX Evolution System Recalled for Unintended X-Ray Exposure

    Carestream Health Inc. is recalling four DRX Evolution System units because they allowed x-ray exposures without an image receptor, resulting in two exposures before an image was captured.

    Product
    Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems compo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0844-2014·2014-02-05

    Carestream Recalls Kodak DirectView DR 7500 Dual Detector Systems

    Carestream Health is recalling 164 Kodak DirectView DR 7500 Dual Detector Systems due to a possible patient image display error.

    Product
    KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2014·2014-01-29

    Carestream DRX-Evolution and Kodak DirectView DR 7500 Recalled for Movement Risk

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 x-ray systems due to potential unexpected device movement.

    Product
    DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray ta
    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.