Recall Z-0467-2013— iwalk inc
Class II · Terminated
Class II FDA medical device recall by iwalk inc, initiated 2012-10-26, terminated 2014-09-26. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Battery may over-heat during charging and smoke.
- Recalling firm
- iwalk inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-26
- Terminated
- 2014-09-26
- Firm location
- Bedford, MA, United States
Product description
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
Reason for recall
Battery may over-heat during charging and smoke
Data sourced from openFDA. This site is unofficial and independent of the FDA.