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
- Affected units
- 15
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
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 →Related recalls
Same manufacturer · Philips North America LLC
See all →- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
Same hazard · notification failure
See all →- HighRayCare 2024A SP1 Oncology Information System Software Recall
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss
FDA (Devices) · 2026-07-08
- HighArial Server Software Fails to Notify Users of Emergency Calls
FDA (Devices) · 2024-12-04
- ModeratePhilips Patient Information Center Custom Ringtones Fail When Screen Locked
FDA (Devices) · 2024-04-03
- ModerateCareEvent Event Management System notification failure on locked iOS devices
FDA (Devices) · 2024-04-03