Philips HeartStart HS1 OnSite Defibrillator Recall: Notification of Previous Recalls
Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.
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 notification failure on previous recalls. No injuries, illnesses, or deaths reported in source. Scored as Moderate due to the administrative and compliance nature of the issue combined with absence of reported active safety defect or patient harm.
Plain-English summary
Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) with specific serial numbers documented in FDA recall Z-0081-2022.
The recall was initiated because customers were not notified of previous recalls associated with these defibrillator models. This notification failure means affected customers may lack awareness of information from prior recalls related to their devices.
The affected units were distributed in the United States (California, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas, and Washington) and internationally (Australia, Canada, France, Germany, Japan, Norway, and Switzerland). Detailed serial number lists for Models M5066A and M5067A are available through FDA Medical Device Recalls database Z-0081-2022.
The recalled product
- Product
- Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
- Manufacturer
- Philips North America LLC
- Hazard
- notification-failure
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 (15)
- Affected serial numbers for Model # M5066A: A11K-03264
- A07A-01278
- B07F-01268
- A10G-05443
- A06E-00929
- A06L-01867
- A06L-01678
- A07J-05837
- A10C-03623
- M5066A-ABD
- A07K-02685
- A09H-03908
- 0205142344
- Expansion - additional serial numbers for Model # M5066A: A11K-08837
- Affected Serial numbers for Model # M5067A: A06K-02421.
Distribution
Distributed in 12 states:
- CA
- CT
- FL
- GA
- IN
- MI
- MO
- NJ
- NY
- OH
- TX
- WA
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