Recall Z-0118-2023— ZOLL Circulation, Inc.

Name: FDA recall Z-0118-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-22

Class II · Ongoing

Class II FDA medical device recall by ZOLL Circulation, Inc., initiated 2022-09-22. It names one FDA 510(k) clearance: K112998. Product: AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR. Reason: Due to increase in Li-Ion Battery failures.

Recalling firm: ZOLL Circulation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-22
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K112998 — AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation·cleared 2012-03-15

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

AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

Reason for recall

Due to increase in Li-Ion Battery failures

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