Recall Z-0078-2022— Philips North America LLC

Name: FDA recall Z-0078-2022
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. It names one FDA 510(k) clearance: K051632. Product: Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A. 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

510(k) clearances named in this recall

1 on FDA's record

K051632 — PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841APhilips Medical Systems·cleared 2005-10-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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