Z-2202-2012Class II

Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150...

Name: Z-2202-2012 Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150...
Creator: Carestream Health, Inc.
Published: 2012-06-12
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2012-06-12 / Terminated / root cause: manufacturing process

FDA source

Carestream Health, Inc. began a recall of 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... on 2012-06-12. FDA classified it as Class II and gives the reason as "Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2202-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-12
Posted: 2012-08-13
Terminated: 2016-05-25
Recalling firm: Eastman Kodak Company
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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 9971 units
Distribution: Worldwide Distribution, including Nationwide (USA).
Product codes and lots: All DRX-1 batteries manufactured before June 2012.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2202-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2202-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-13

Product code MQB

K090318Class IICarestream Drx-1 SystemCarestream Health, Inc. / cleared 2009-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)