Open, Classified

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

FDA Recall Z-0118-2023 · Posted 2022-10-21

Recalling FirmZOLL Circulation, Inc.

Recall StatusOpen, Classified

Product CodeDRM

Date Initiated2022-09-22

Product Quantity6,353 batteries

Reason for Recall

Due to increase in Li-Ion Battery failures

Firm Action

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 [email protected] 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

Distribution Pattern

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 Islands, WA, WI, WV and WY. O.U.S.: United Arab Emirates, Austria, Australia, Azerbaijan, Brazil, Belarus, Canada, Switzerland, China, Costa Rica, Germany, Denmark, Egypt, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Moldova, Mexico, Malaysia, Netherlands, Norway, Panama, Philippines, Poland, Qatar, Romania, Russian, Saudi Arabia, Singapore, Slovenia, Taiwan, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation · 2012-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.