Recall Z-0297-2024 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
| Date | Nov 14, 2023 (initiated Sep 29, 2023) |
| Status | Open, Classified |
| Reason | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. |
| Root cause | Under Investigation by firm |
| Action | On October 6, 2023, Stryker issued a "Urgent Medical Device Correction" Notification to affected consignees. Stryker ask consignees to take the following actions: 1. Please check your internal inventory to locate the affected product listed on the attached business reply form. 2. To confirm receipt of this Medical Device Notice and understanding of the provided information, please email the enclosed Business Reply Form (BRF) by October 31, 2023, to RSRecall@Stryker.com. 3. Once the BRF is received, a Stryker Representative will contact you to arrange for corrective action on the device. The |
| Quantity | 8 yrs. |
| Distribution | US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.