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DRX-Revolution Mobile X-Ray System
- Starting date:
- May 11, 2017
- Posting date:
- June 7, 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-63532
Reason
Carestream Health has identified an issue with the DRX-Revolution Mobile X-Ray system that could result in separation of the tube and yoke assembly. Carestream found a single device where four screws in the assembly were not applied in the manufacturing process. To date, Carestream has found only a single system where this failure has occurred and considers it unlikely that there are other DRX-Revolution Mobile X-ray systems where this step was missed. There was no injury associated with this failure.
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