RegWardenFDA facility compliance records
Facility

Carestream Health, Inc

30 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 1 recalls; 2013: 11 recalls; 2014: 6 recalls; 2015: 2 recalls; 2016: 3 recalls, 1 inspections; 2017: 2 recalls; 2019: 1 recalls, 1 inspections; 2020: 1 recalls; 2022: 1 inspections; 2023: 3 recalls1’1211’136’142’154’162’17’182’191’20’211’223’23’24’25’26
  • Recalls (30)
  • Inspections (3)

Devices registered here (1)

Recalls & enforcement

20233 records
  • Class IIOngoing2023-10-02
    There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like …
  • Class IIOngoing2023-10-02
    Unexpected failure of electrical components within the CPI generator.
  • Class IIOngoing2023-01-30
    After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury
20201 record
20191 record
  • Class IITerminated2019-03-19
    When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
20172 records
  • Class IITerminated2017-05-25
    Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
  • Class IITerminated2017-01-12
    The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
20163 records
  • Class IITerminated2016-11-21
    Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.e., centimeters or millimeters. As such, the user expects t…
  • Class IITerminated2016-07-08
    A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
  • Class IITerminated2016-04-15
    Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".
20152 records
  • Class IITerminated2015-08-07
    Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
  • Class IITerminated2015-01-08
    Units device head descended unexpectedly
20146 records
  • Class IITerminated2014-11-25
    While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray tube assembly/boom to the device mounting bl…
  • Class IITerminated2014-10-30
    Reduced mammographic image quality when attempting to print true size multi-format images
  • Class IITerminated2014-07-09
    An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer wa…
  • Class IIITerminated2014-07-02
    The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by refer…
  • Class IITerminated2014-05-30
    A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device co…
  • Class IITerminated2014-01-24
    Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
201311 records
  • Class IITerminated2013-12-26
    Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
  • Class IITerminated2013-11-25
    Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
  • Class IITerminated2013-09-16
    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.
  • Class IITerminated2013-08-29
    It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.
  • Class IITerminated2013-08-29
    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 Dete…
  • Class IITerminated2013-08-20
    Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image re…
  • Class IITerminated2013-07-26
    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.
  • Class IITerminated2013-06-19
    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.
  • Class IITerminated2013-06-06
    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.
  • Class IITerminated2013-06-03
    Due to potential for an x-ray exposure technique change.
  • Class IIITerminated2013-01-17
    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 …
20121 record
  • Class IITerminated2012-06-12
    Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.

FDA inspections (3)

  • NAI2022-10-20
    No Action Indicated · Radiation Control and Health Safety Act
  • NAI2019-04-09
    No Action Indicated · Radiation Control and Health Safety Act
  • NAI2016-06-30
    No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Carestream Health, Inc (FEI 1317307) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1317307-carestream-health-inc/

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