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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 Recall
Carestream DRX1 System battery
see related information
Date Posted August 13, 2012
Recall Status1 Open
Recall Number Z-2202-2012
Recall Event ID 62310
Premarket Notification
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, New York 14615-2731
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = CARESTREAM HEALTH, INC.
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