Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St,
FDA device recall Z-2202-2012 · posted 2012-08-13 · Terminated
Recall details
- Recalling firm
- Carestream Health, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 9971 units
- Distribution
- Worldwide Distribution, including Nationwide (USA).
- Date initiated
- 2012-06-12
- Date posted
- 2012-08-13
- Date terminated
- 2016-05-25
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARESTREAM DRX-1 SYSTEM (K090318) | Carestream Health, Inc. | 2009-04-06 |