Recall Z-0118-2023
ZOLL Circulation, Inc. · initiated September 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
Codes / lots: Model Number: 100 UDI-DI Codes: (01)00849110 Part Nos. 12742-001 12742-002 12742-003 12742-004 12742-005 12742-006 12742-008 12742-009 12742-010 12742-011 12742-012 12742-013 12742-014 12742-007 12742-015 12742-016 12742-017 12742-019 Serial Numbers: U.S. 6530 6532 6539 6541 6542 6543 6549 6550 6553 6554 6555 6556 6557 6559 6563 6564 6565 6566 6572 6573 6575 6576 6577 6578 6580 6581 6582 6583 6586 6588 6589 6590 6591 6595 6597 6598 6599 6602 6605 6606 6608 6609 6611 6612 6613 6614 6617 6619 6620 6621 6622 6623 6626 6627 6628 6630 6632 6635 6636 6638 6639 6641 6642 6644 6645 6647 6650 6652 6653 6654 6655 6656 6658 6659 6660 6661 6662 6663 6665 6667 6668 6669 6670 6671 6672 6674 6677 6679 6681 6682 6683 6684 6685 6688 6690 6691 6692 6693 6694 6695 6696 6697 6698 6699 6700 6701 6702 6704 6705 6706 6707 6708 6709 6710 6711 6712 6713 6714 6715 6716 6717 6718 6719 6720 6721 6722 6724 6725 6726 6727 6728 6729 6730 6732 6734 6735 6736 6737 6738 6739 6740 6742 6744 6745 6746 6747 6749 6750 6751 6752 6753 6754 6755 6756 6757 6758 6759 6760 6761 6763 6764 6765 6767 6768 6769 6770 6771 6773 6774 6777 6792 6802 6806 6810 6827 6836 6841 6845 6851 6852 6853 6854 6855 6856 6857 6858 6861 6863…
Reason for recall
Due to increase in Li-Ion Battery failures
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0118-2023
- Initiated
- September 22, 2022
- Posted by FDA
- October 21, 2022
- Product code
- DRM – Compressor, Cardiac, External
- 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, Belarus, Canada, Switzerland, China, Costa Rica, Germany, Denmark, Egypt, France, United Kingdom…
- Recalling firm
- ZOLL Circulation, Inc., San Jose, CA