Recall Z-0567-2024 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
| Date | Dec 15, 2023 (initiated Nov 6, 2023) |
| Status | Open, Classified |
| Reason | AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA. |
| Root cause | Component change control |
| Action | On 11/06/23, Recall and Field Safety Alert notices were sent to customers. The recall notices asked customers to do the following: 1) Complete and return business reply form by email to RSRecall@stryker.com 2) Firm recommends continued use. Follow the OI recommendations for daily inspection and testing according to the checklist provided in the Operating Instructions. a. The checklist includes disconnecting the defibrillator from the power adapter, turning the device on, and confirming that two batteries are installed and charged. Then, the defibrillator should be reconnected to the power a |
| Quantity | 18,732 |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.