Z-0080-2022 Class II Ongoing
FDA device recall Z-0080-2022 was initiated by Philips North America LLC on February 9, 2021 and is designated Class II. Reason for recall: Customers were not notified of previous recalls associated with various defibrillator models. The recall status is ongoing. Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- February 9, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Reason for Recall
Customers were not notified of previous recalls associated with various defibrillator models.
Distribution Pattern
U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
Code Information
Affected serial numbers for Model # 5068A: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, 1007257517