Z-0078-2022 Class II Ongoing
FDA device recall Z-0078-2022 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: 4 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
- 4 units
Product Description
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
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
Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514