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.
FDA Recall Z-2202-2012 · Posted 2012-08-13
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Recalling FirmCarestream Health, Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2012-06-12
Date Terminated2016-05-25
Product Quantity9971 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution, including Nationwide (USA).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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