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DRX-Revolution Mobile X-Ray System
- Starting date:
- January 4, 2017
- Posting date:
- January 25, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61946
Reason
Carestream Health has identified an issue with the DRX-Revolution Mobile X-ray System that could result in unintended motion. Carestream's investigation found that the pivot screws in the drive handle can back out and interfere with the driving mechanism. The backed out screw can interfere with operator control of the DRX revolution and result in unintended motion. The investigation revealed that thread locking compound applied in the manufacturing process to secure this screw was not always applied as it should. To date, Carestream has found only a single system where this failure has occurred, there was no resulting injury, but the problem could manifest in additional units over the life of the device.
Affected products
DRX-Revolution Mobile X-Ray System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 1019397
Companies
- Manufacturer
-
Carestream Health, Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES