Z-1547-2010

ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll...

Name: Z-1547-2010 ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll...
Creator: ZOLL Medical Corporation, World Wide Headquarters
Published: 2010-03-24
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2010-03-24 / Terminated / root cause: software

FDA source

ZOLL Medical Corporation, World Wide Headquarters began a recall of ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for... on 2010-03-24. The reason FDA records is "Device issued Shock Advised message but failed to auto-charge the defibrillator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1547-2010
Status: Terminated
Initiated: 2010-03-24
Posted: 2010-05-07
Terminated: 2014-01-23
Recalling firm: ZOLL Medical Corporation
Product: ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Device issued Shock Advised message but failed to auto-charge the defibrillator.
Root cause tag: software
FDA root cause: Software design
Action: Zoll Medical Corporation issued an "Urgent Medical Device Correction" notification dated March 26, 2010 via certified mail to consignees who have received affected product. Customers will be contacted and given the option to have a software upgrade kit to update their devices or return devices to the firm to have the device upgraded. For further information, contact Zoll Medical Corporation 24/7 Technical Support at 1-800-348-9011 or 1-978-421-9460.
Quantity in commerce: 1383 units
Distribution: Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom.
Product codes and lots: Software versions 4.XX, 6.XX and 7.0X in the E Series BLS Model.

Product code MKJ

K042007Class IIIZoll E Series DefibrillatorZoll Medical Corp / cleared 2005-04-07

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)