Z-0062-2010

Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG...

Name: Z-0062-2010 Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG...
Creator: Philips Medical Systems
Published: 2009-10-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-10-01 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems began a recall of Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and... on 2009-10-01. The reason FDA records is "A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy". 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-0062-2010
Status: Terminated
Initiated: 2009-10-01
Posted: 2009-12-08
Terminated: 2013-09-27
Recalling firm: Philips North America LLC
Product: Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool. For further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit www.philips.com/FR2PlusAction for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.
Quantity in commerce: see Z-0063-2010
Distribution: Domestic and Worldwide distribution to: United States, Canada, Australia, Austria, Bulgaria, China, Finland, France, Germany, Gibraltar, Great Britain, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates.
Product codes and lots: The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and AC4=Portugal. Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement.

Product code MKJ

K051632Class IIIPhilips Heartstart Fr2+ Automated External Defibrillator, Models M3860a, M3861a, M3840a, M3841aPhilips Medical Systems / cleared 2005-10-05

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)