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U.S. Department of Health and Human Services

Class 2 Device Recall BiOMBiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium

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 Class 2 Recall
BiOMBiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium
see related information
Date Posted December 04, 2012
Recall Status1 Open
Recall Number Z-0467-2013
Recall Event ID 63646
Product Classification Assembly, Knee/Shank/Ankle/Foot, External - Product Code ISW
Product BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
Code Information Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973
Recalling Firm/
Manufacturer
iwalk inc
4 Crosby Dr
Bedford, Massachusetts 01730-1402
Manufacturer Reason
for Recall
Battery may over-heat during charging and smoke
Action iWalk notified customers directly by sales representatives by telephone on October 26, 2012, and instructedthem to stop use of the battery and charger and return them to iWalk. Accounts provided with Return Material Authorizations (RMA). For questions regarding this recall call 781-761-1560.
Quantity in Commerce 21 Batteries; 9 Chargers
Distribution Nationwide Distribution including OH, NC, and NY.
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
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