Recall Z-0467-2013 ยท ISW Assembly, Knee/Shank/Ankle/Foot, External
iwalk inc
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
| Date | Dec 4, 2012 (initiated Oct 26, 2012) |
| Status | Terminated |
| Reason | Battery may over-heat during charging and smoke |
| Root cause | Unknown/Undetermined by firm |
| 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 | 21 Batteries; 9 Chargers |
| Distribution | Nationwide Distribution including OH, NC, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.