Recall Z-2202-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
| Date | Aug 13, 2012 (initiated Jun 12, 2012) |
| Status | Terminated |
| 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). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090318 | CARESTREAM DRX-1 SYSTEM Carestream Health, Inc., Apr 6, 2009 |