There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Reason for recall: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia. Quantity: 21,490 eaches Lot/code info: GTIN: 07613327117196 Lot Numbers: 53867671 54409847 59053476 64855502 66494932
07613327117196
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.