Medical DeviceDec 13, 2023
Carestream Health DRX Revolution Mobile X-Ray System recall — FDA Z-0437-2024
Unexpected failure of electrical components within the CPI generator.
Class IIFDA: OngoingCarestream Health, Inc.
Recall history in this database
Classification mix: Class II: 12.
Medical DeviceNov 15, 2023
Carestream Health The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system recall — FDA Z-0289-2024
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…
Class IIFDA: OngoingCarestream Health, Inc.
Medical DeviceMar 8, 2023
Carestream Health DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4 recall — FDA Z-1206-2023
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…
Class IIFDA: OngoingCarestream Health, Inc.
Medical DeviceJan 22, 2020
Carestream Health Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a recall — FDA Z-0806-2020
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Class IIFDA: TerminatedCarestream Health, Inc.
Medical DeviceMay 1, 2019
Carestream Health OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog recall — FDA Z-1207-2019
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…
Class IIFDA: TerminatedCarestream Health, Inc.
Medical DeviceJul 5, 2017
Carestream Health DRX-Revolution Mobile X-Ray System recall — FDA Z-2651-2017
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 IIFDA: TerminatedCarestream Health Inc.
Medical DeviceFeb 15, 2017
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 recall — FDA Z-1138-2017
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.
Class IIFDA: TerminatedCarestream Health Inc.
Medical DeviceJan 25, 2017
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound recall — FDA Z-1052-2017
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…
Class IIFDA: TerminatedCarestream Health Inc.
Medical DeviceJul 27, 2016
Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog recall — FDA Z-2217-2016
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…
Class IIFDA: TerminatedCarestream Health Inc.
Medical DeviceMay 11, 2016
CARESTREAM Image Suite V4 recall — FDA Z-1594-2016
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…
Class IIFDA: TerminatedCarestream Health Inc.
Medical DeviceMay 11, 2016
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490 recall — FDA Z-1593-2016
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…
Class IIFDA: TerminatedCarestream Health Inc.
Medical DeviceSep 2, 2015
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed recall — FDA Z-2449-2015
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…
Class IIFDA: TerminatedCarestream Health Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Carestream Health, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.