Moderate FDA (Devices)·Z-0080-2022·Announced 2021-10-20

Philips HeartStart HS1 Home Defibrillator: Customers Not Notified of Previous Recalls

Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II medical device with a notification failure as the primary issue. No illness, injury, or death has been reported. The failure to communicate previous recalls is a documentation and compliance matter rather than an active product defect.

Plain-English summary

Philips North America LLC is recalling the HeartStart HS1 Home Defibrillator (Model M5068A) due to a failure to notify customers of previous recalls associated with various defibrillator models.

Nine units of the M5068A with the following serial numbers are affected: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, and 1007257517.

The affected devices were distributed in the United States (California, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas, and Washington) and internationally in Australia, Canada, France, Germany, Japan, Norway, and Switzerland.

The recalled product

Product: Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Manufacturer: Philips North America LLC
Category: Medical Device — Defibrillator
Hazard: notification-failure
Affected units: 9

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 (9)

Affected serial numbers for Model # 5068A: A10A-01936
A09J-02570
A04L-01521
A10H-04433
A09J-01944
A07H-03121
A08A-03450
A08A-05842
1007257517

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 →

Same manufacturer · Philips North America LLC

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