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U.S. Department of Health and Human Services

Class 2 Device Recall 3.7 V LiPolymer Battery

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 Class 2 Recall
3.7 V LiPolymer Battery
see related information
Date Posted February 06, 2009
Recall Status1 Open
Recall Number Z-0971-2009
Recall Event ID 50790
Premarket Notification
510(K) Numbers
K053462  K063559 
Product Classification Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) - Product Code MWI
Product 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826 These rechargeable batteries are used to supply power to patient monitoring system's wireless modules and gating/triggering systems' fiber optic modules.
Code Information date codes 2808 and lower.
Recalling Firm/
Manufacturer
Invivo Corporation
12501 Research Pkwy
Orlando, Florida 32826-3280
Manufacturer Reason
for Recall
Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, when dropped from 3 feet/1 meter onto a hard surface can produce a flame and then emit smoke. The firms investigation shows that the battery failure does not occur when a module is dropped with a ba
FDA Determined
Cause 2
DESIGN: Process Design
Action Urgent Medical Device Recall Notice letters, dated August 2008, and response forms were mailed to each consignee. Distributors were instructed to forward copies of the recall letter and response forms to their customers. The letters identified the affected products, gave the reason for the recall, the hazard involved, how to identify the product, actions to prevent the failure, and procedures to mitigate risk if failure occurs. The letter stated that Invivo would provide replacement batteries but until replacements were provided, customers should handle batteries over an elevated area and to make sure batteries are handled in the absence of paper or other flammable materials. If customers wish to remove the battery from the module in order to conserve battery life, they are to disengage the battery from the module and place the battery on a table or in the battery charger. Do not allow the battery to be disengaged and remain partially inserted in the module as this may cause the battery to slip from the module and fall to the floor.
Quantity in Commerce 8,476
Distribution Worldwide Distribution
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 = MWI and Original Applicant = INVIVO CORPORATION
510(K)s with Product Code = MWI and Original Applicant = PHILIPS MEDICAL SYSTEMS
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