Recall Z-0816-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
| Date | Dec 20, 2019 |
| Status | Terminated |
| Reason | Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button. |
| Root cause | Device Design |
| Action | On 12/20/19, Urgent Medical Device Safety Notice & Correction Action Required notifications were mailed to customers informing them to review the affected device list (www.strykeremergencycare.com/fa282response). Upon confirmation of device status, field service personnel will contact you to arrange for the correction of the device, which will include a replacement of the affected keypad. The devices subject to this correction are planned to be serviced by June 30, 2021. You may continue to use affected Monitors/Defibrillators according to the Operating Instructions until the correction can |
| Quantity | 29952 |
| Distribution | Worldwide Distribution - U.S Nationwide: GA, PA, IN, CA, KY, FL, AZ, WA, NC, MD, TX, CO, VT, MI, MA, TN, OH, CT, NY, MO, VA, IA, MN, LA, WV, MT, IL, AR, UT, NJ, OK, NV, NH, MS, NM, WI, OR, ID, SC, NE, AK, SD, AL, WY, RI, KS, ME, DE, ND, DC, HI, PR O.U.S. (Foreign): Germany, Netherlands, Hong Kong, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142430 | LIFEPAK 15 monitor/defibrillator Physio-Control, Inc., Dec 19, 2014 |