Device product
Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
Z-2202-2012
Product summary
- Event
- Event 62310
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9971 units
- Official record key
device-enforcement:Z-2202-2012
Official wording
Reason: Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.
Code information: All DRX-1 batteries manufactured before June 2012.
Distribution pattern: Worldwide Distribution, including Nationwide (USA).
Derived failure modes
-
Unknown
Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.