The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0079-2022·Announced 2021-10-20

Philips Defibrillators Recall: Customers Uninformed of Previous Recalls

Customers of Philips HeartStart FRx defibrillators were not notified of previous recalls associated with various defibrillator models. This is a Class II medical device recall.

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 is an FDA Class II medical device recall involving failure to notify customers of previous recalls. Although no illnesses or injuries are reported, this notification failure on a medical device creates a risk-of-harm situation where customers are unaware of previously identified issues.

Plain-English summary

Philips North America LLC has issued a recall of the HeartStart FRx defibrillator (Model 861304). This is an FDA Class II medical device.

The recall stems from a notification failure: customers were not notified of previous recalls associated with various defibrillator models. This left device users unaware of issues identified in earlier recall actions.

The affected devices have been distributed within the United States in California, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas, and Washington. International distribution includes Australia, Canada, France, Germany, Japan, Norway, and Switzerland. Six units are involved in this recall.

Customers with affected devices should contact Philips North America LLC with their device model and serial number to obtain information about the previous recalls.

The recalled product

Product
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Manufacturer
Philips North America LLC
Category
Medical Device — Defibrillator
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Model 861304 serial number: 0805164058
  • B12C-03067
  • B07I-01107
  • B09D-01464
  • B08L-00595
  • B10I-03918

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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