Product Wiki · Recalls · U.S. FDA — Device Enforcement

Carestream DRX-1 System Battery --- Made in U.S.A — recall Z-2202-2012

U.S. FDA — Device Enforcement · United States · 2012-06-12 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2202-2012
Date of alert
2012-06-12
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Carestream Health, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution, including Nationwide (USA).
Reported risk: Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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