Recall Z-0230-2025 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.
| Date | Oct 25, 2024 (initiated Aug 30, 2024) |
| Status | Open, Classified |
| Reason | Due to an out of tolerance tool being used on monitor/defibrillator systems. |
| Root cause | Vendor change control |
| Action | On 09/30/2024, the firm mailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them that Stryker discovered that an out of tolerance service tool was used on affected LP15 devices in which there is a potential for Noninvasive Blood Pressure (NIBP), System or Auxiliary Power Connectors to be loose. There is a possibility that water or dust may accumulate in the ingress and can lead to permanent or intermittent failures. Customers are instructed to: 1. Immediately check internal inventory to locate the product listed on the attached business reply form. 2. To confirm recei |
| Quantity | 105 systems |
| Distribution | U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.