The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0078-2022·Announced 2021-10-20

Philips HeartStart Defibrillator Recall: Previous Recall Notifications Not Sent

Philips HeartStart FR2+ Defibrillators (models M3860A and M3861A) were not accompanied by notifications about previous recalls. Affected customers should contact Philips for information about prior safety issues.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall addresses a failure to notify customers about previous recalls for a critical medical device. While no illnesses or injuries have been reported, the notification failure for a defibrillator constitutes a risk-of-harm situation that meets the criteria for High severity.

Plain-English summary

Philips HeartStart FR2+ Defibrillators (Model M3860A and M3861A) are the subject of this recall. Customers with certain units were not notified about previous recalls that had been issued for various defibrillator models.

Without knowledge of previous recalls, customers cannot take appropriate action regarding any previously identified safety concerns with their devices. For a critical medical device such as a defibrillator, ensuring that users are informed of all safety issues is essential.

Four affected units have been identified. Distribution includes parts of the United States (California, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas, and Washington) as well as international locations (Australia, Canada, France, Germany, Japan, Norway, and Switzerland). Affected serial numbers are: Model M3860A (A09G-04198, 510800626) and Model M3861A (A09H-00436, A07J-03514).

Customers who own these defibrillators should contact Philips North America LLC to learn about any previous recalls and determine whether their device is affected.

The recalled product

Product
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Manufacturer
Philips North America LLC
Category
Medical Device — Cardiac defibrillator
Hazard
Affected units
4

Distribution

Distributed in 12 states:

Part of a larger recall action

This product is one of 4 recalled by Philips North America LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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