Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
BiOMBiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium		see related information
Date Posted December 04, 2012
Recall Number Z-0467-2013
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
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.
 
-
-