Recall Z-0080-2022— Philips North America LLC

Name: FDA recall Z-0080-2022
Creator: U.S. Food and Drug Administration
Published: 2021-02-09

Class II · Ongoing

Class II FDA medical device recall by Philips North America LLC, initiated 2021-02-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A. Reason: Customers were not notified of previous recalls associated with various defibrillator models..

Recalling firm: Philips North America LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-02-09
Firm location: Bothell, WA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.