Z-0078-2022Class II

Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

Name: Z-0078-2022 Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Creator: Philips North America LLC
Published: 2021-02-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-02-09 / Open, Classified / root cause: manufacturing process

FDA source

Philips North America LLC began a recall of Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A on 2021-02-09. FDA classified it as Class II and gives the reason as "Customers were not notified of previous recalls associated with various defibrillator models". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0078-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-09
Posted: 2021-10-08
Recalling firm: Philips North America LLC
Product: Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Customers were not notified of previous recalls associated with various defibrillator models.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 11, 2021, Philips issued a "Urgent - Safety Notification" to affected consignees via certified Mail. In addition to notifying consignees that may have been omitted from notification of one or more recalls, Philips asked affected consignees to take 1. To acknowledge receipt of this notification, please complete and return the Customer Reply Form by email or by fax by February 15, 2021. Email to: [email protected] Or, Fax: 1 (833) 371-1011 2. A Philips representative will reach out to you to help you identify any affected AED. 3. After it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be provided. 4. The affected AED may remain in service until you receive a replacement Philips AED. 5. Philips will exchange affected devices with a replacement Philips AED free of charge. 6. If you need any further information or support concerning this issue, please contact Philips at 1 (800) 263-3342. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 4 units
Distribution: U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
Product codes and lots: Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0078-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0078-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-20	2021-10-08
Z-0079-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-20	2021-10-08
Z-0080-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-20	2021-10-08
Z-0081-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-20	2021-10-08

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)