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

FDA device recall Z-0118-2023 · posted 2022-10-21 · Open, Classified

Recall details

Recalling firm

ZOLL Circulation, Inc.

Reason for recall

Due to increase in Li-Ion Battery failures

Action taken

On 09/22/2022, the firm sent an "MEDICAL DEVICE PRODUCT CORRECTION NOTICE" via First Class Mail to customers informing them that ZOLL Circulation observed an increase in battery complaints of fully charged batteries no powering on the AutoPulse Platform. Investigations revealed that batteries stored at elevated temperatures were failing and are potentially due to a supplier switching to an alternate electrical component and thermal variation within specification of a second electrical component. Customers are instructed to: 1. Complete the Customer Acknowledgement/No-Charge Battery Replacement Request Form and email it to APBattery2022@zoll.com as soon as possible. 2. While waiting for the replacement batteries to arrive, do not store the affected batteries in a hot environment prior to use such as in a hot vehicle, in the sun, or in a hot room. Storing the affected batteries in a hot environment may prevent the batteries from powering on the AutoPulse Platform. Note that the affected batteries will power on the AutoPulse Platform after they are allowed to cool.

Root cause

Device Design

Status

Open, Classified

Product code

DRM

Quantity affected

6,353 batteries

Distribution

U.S.: AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, RN, TX, UT, VA, VT, Virgin Is

Date initiated

2022-09-22

Date posted

2022-10-21

Location

San Jose, CA

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