DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiogra
FDA device recall Z-1206-2023 · posted 2023-03-02 · Open, Classified
Recall details
- Recalling firm
- Carestream Health, Inc.
- Reason for recall
- 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
- Action taken
- Carestream issued Urgent Medical Device Correction Letter to Director of Radiology, Chief Radiology Administrator and DRX-Compass/DR-FIT X-ray System Administrators (US) consignees on 1/30/23. Letter states reason for recall, health risk and action to take: Do not use the Z-Axis Motorized button on the Tube Head Display at this time. Use the Brake Release buttons (Items 5 or 8) to manually move the OTC in the Z-Axis. " Press any E-stop button to stop unexpected movement immediately. " A Service Representative will install a Firmware correction. Action to be taken: A Carestream Service Engineer or Carestream Health Authorized Representative will contact your site and setup a service call to inspect your device and install a new firmware version. For your convenience, a Notification Acknowledgement form has been provided with this letter. Please read and complete the information within 5 working days. Remit the completed form by e-mail to: postmarketra@carestream.com. Questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Carestream S vice support number
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- KPR
- Quantity affected
- 72 units
- 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, Aust
- Date initiated
- 2023-01-30
- Date posted
- 2023-03-02
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRX-Compass (K201373) | Carestream Health, Inc. | 2020-06-26 |