Z-0081-2022 Class II Ongoing
FDA device recall Z-0081-2022 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: 15 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
- 15 units
Product Description
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
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 # 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.