Recall Z-2202-2012— Carestream Health, Inc.

Name: FDA recall Z-2202-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-12

Class II · Terminated

Class II FDA medical device recall by Carestream Health, Inc., initiated 2012-06-12, terminated 2016-05-25. It names one FDA 510(k) clearance: K090318. 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.. Reason: Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns..

Recalling firm: Carestream Health, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-12
Terminated: 2016-05-25
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K090318 — CARESTREAM DRX-1 SYSTEMCarestream Health, Inc.·cleared 2009-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.

Data sourced from openFDA. This site is unofficial and independent of the FDA.