Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0467-2013 · Posted 2012-12-04

Recalling Firmiwalk inc
Recall StatusTerminated
Product CodeISW
Date Initiated2012-10-26
Date Terminated2014-09-26
Product Quantity21 Batteries; 9 Chargers

Reason for Recall

Battery may over-heat during charging and smoke

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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Nationwide Distribution including OH, NC, and NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑