life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L8

FDA device recall Z-0521-2008 · posted 2008-01-26 · Terminated

Recall details

Recalling firm

Exocomm Tech Grp

Reason for recall

Marketed without a 510K

Action taken

The original recall communication was sent out on 9/3/07 by Phoenix Solutions, a consultant to Battery Zone, as a Dear Valued Customer notice. A second recall communication, Urgent Device Recall Letter, was issued by Exxocom Technology Group dated 10/25, was sent out to all customer (even those who had returned product) on 11/5/07. Both communication were sent by first class mail, requesting return of batteries

Root cause

PMA

Status

Terminated

Product code

MKJ

Quantity affected

46 units

Distribution

Worldwide-Batteries were distributed to dealers or distributors in CT, GA, MN, NC, NY, OH, OK, OR, PA and TN plus one Canadian Consignee

Date initiated

2007-09-03

Date posted

2008-01-26

Date terminated

2013-07-01

Location

Allentown, PA