Reported Oct 20, 2021 · Ongoing

Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304

Philips North America LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America LLC · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431

Is this the product you have?

  • Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Lot codes and dates
  • Model 861304 serial number
    • 0805164058
    • B12C-03067
    • B07I-01107
    • B09D-01464
    • B08L-00595
    • B10I-03918
Amount recalled
6 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Customers were not notified of previous recalls associated with various defibrillator models.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 PM UTC

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