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Recall Observatory FDA recall evidence

Device 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

Z-0467-2013

October 26, 2012

Class II

Product summary

Firm
iwalk inc
Event
Event 63646
Status
Terminated
Classification
Class II
Quantity
21 Batteries; 9 Chargers
Official record key
device-enforcement:Z-0467-2013

Official wording

Reason: Battery may over-heat during charging and smoke

Code information: Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973

Distribution pattern: Nationwide Distribution including OH, NC, and NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Battery may over-heat during charging and smoke