Recall Z-0118-2023 ยท DRM Compressor, Cardiac, External
ZOLL Circulation, Inc.
AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
| Date | Oct 21, 2022 (initiated Sep 22, 2022) |
| Status | Open, Classified |
| Reason | Due to increase in Li-Ion Battery failures |
| Root cause | Device Design |
| 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 Replaceme |
| Quantity | 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 Islands, WA, WI, WV and WY. O.U.S.: United Arab Emirates, Austria, Australia, Azerbaijan, Brazil, Bel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 Zoll Circulation, Mar 15, 2012 |