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U.S. Department of Health and Human Services

Class 2 Device Recall Carestream DRX1 System battery

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  Class 2 Device Recall Carestream DRX1 System battery see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = CARESTREAM HEALTH, INC.
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