Rochester, NY, United States
Carestream Health, Inc. recalls
5 recalls recorded since 2018, most recently on 2 October 2023. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)3
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 October 2023
- Reason
- Unexpected failure of electrical components within the CPI generator.
- Distribution
- Worldwide Distribution: US (Nationwide Distribution); and OUS (Foreign): Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Dominican Rep., Finland, France, Germany, Ghana, Great Britain, Hong Kong, Hungary, India, Indonesia, Iran, Ire
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0437-2024
- DRX Revolution Mobile X-Ray System
Ongoing Class II Medical devices
- Recall started
- 2 October 2023
- Reason
- 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 this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0289-2024
- 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 so
Ongoing Class II Medical devices
- Recall started
- 30 January 2023
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of California, Idaho, Illinois, Massachusetts, Minnesota, Nevada, North Carolina, Texas Wisconsin and the countries of Argentina, Australia, Brazil, China, Finland, France, INDIA, ITALY, Korea, Malaysia, Poland, Republic of Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1206-2023
- 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
Terminated Class II Medical devices
- Recall started
- 6 January 2020
- Terminated
- 29 May 2020
- Reason
- Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
- Distribution
- Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0806-2020
- 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 interf
Terminated Class II Medical devices
- Recall started
- 19 March 2019
- Terminated
- 27 April 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: Arizona, California, New York, Alabama, Georgia, Georgia, Illinois, Minnesota, New York, Oregon, Pennsylvania; and countries of: IRAN, ITALY, JERUSALEM, KOREA, PHILIPPINES, PORTUGAL,SAUDI ARABIA, SINGAPORE, SWITZERLAND THAILAND, and UNITED KINGD
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1207-2019
- 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 projecti
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.