Date Initiated by Firm | June 12, 2012 |
Date Posted | August 13, 2012 |
Recall Status1 |
Terminated 3 on May 25, 2016 |
Recall Number | Z-2202-2012 |
Recall Event ID |
62310 |
510(K)Number | K090318 |
Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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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. |
Code Information |
All DRX-1 batteries manufactured before June 2012. |
Recalling Firm/ Manufacturer |
Carestream Health, Inc. 1049 Ridge Rd W Rochester NY 14615-2731
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For Additional Information Contact | 585-781-1997 |
Manufacturer 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. |
FDA Determined Cause 2 | 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). |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MQB
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