Recalling Firm / Manufacturer

Medtronic Emergency Response Systems, Inc.

Product

Batteries used with the LIFEPAK 20 defibrillator/monitor

Code Information

Battery Product Part Number: 3200497-000 Battery lot codes: prior to 0539; lot codes: 05 265 or 05 266.

Reason of Recall

Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.

Date Recall Initiated

March 30, 2007

Action

Firm sent letters on 03/30/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK 20 devices. The firm advised consignees to use the Operator's Checklist in the Operating Instructions to perform daily user tests and function checks while operating the defibrillator on battery power. In addition consignees are advised to replace their battery every 1 to 2 years. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA 

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.