FDA Medical Device Recalls (openFDA)
Carestream Health, Inc.: 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.
- Recall number
- Z-2202-2012
- Recalling firm
- Carestream Health, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2012-06-12
- Posted
- 2012-08-13
- Terminated
- 2016-05-25
- Reason
- Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.
- Root cause
- Nonconforming Material/Component
- Action
- Firm sent consignees "Urgent: Customer Notification and Field Corrective Action" letters on June 8, 2012. The letters described the issue and provided recommended actions. Service dealers will contact all affected consignees to evaluate the battery. U.S. customers with questions can contact Carestream Customer Care at 800-328-2910. Customers outside the United States should contact their local Carestream service number.
- Quantity
- 9971 units
- Distribution
- Worldwide Distribution, including Nationwide (USA).
- Lot, serial or model codes
- All DRX-1 batteries manufactured before June 2012.
- 510(k) numbers
- ["K090318"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 1317307
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28