Z-0521-2008

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

Name: Z-0521-2008 life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide...
Creator: Exocomm Tech Grp
Published: 2007-09-03
License: https://open.fda.gov/license/

Exocomm Tech Grp / initiated 2007-09-03 / Terminated

FDA source

Exocomm Tech Grp began a recall of life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for... on 2007-09-03. The reason FDA records is "Marketed without a 510K". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0521-2008
Status: Terminated
Initiated: 2007-09-03
Posted: 2008-01-26
Terminated: 2013-07-01
Recalling firm: Exocomm Tech Grp
Product: life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Marketed without a 510K
FDA root cause: PMA
Action: 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
Quantity in commerce: 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
Product codes and lots: All Serial Numbers

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)