Z-1195-2010

Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A

Name: Z-1195-2010 Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A
Creator: Philips Medical Systems
Published: 2009-11-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-11-02 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems began a recall of Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A on 2009-11-02. The reason FDA records is "Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1195-2010
Status: Terminated
Initiated: 2009-11-02
Posted: 2010-03-23
Terminated: 2013-05-23
Recalling firm: Philips North America LLC
Product: Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.
Quantity in commerce: 1 unit internationally
Distribution: Worldwide Distribution.
Product codes and lots: Serial number A09J-02205

Product code MKJ

K020715Class IIIPhilips M5066a and M5068aPhilips Medical Systems / cleared 2002-11-08

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)