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.
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 2/5 (Moderate).
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
- 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
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.
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