Recall Z-1123-2017 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
| Date | Feb 11, 2017 (initiated Jan 12, 2017) |
| Status | Terminated |
| Reason | The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA). |
| Root cause | Other |
| Action | Physio plans to send the URGENT MEDICAL DEVICE CORRECTION ACTION REQUIRED LIFEPAK 15 Monitor/Defibrillator letter, dated January 2017, to their consignees on January 12, 2017. They were informed of the problem and how to identify a malfunction during the User Test of the device as described in the chapter titled Maintaining the Equipment within the LIFEPAK 15 Operating Instructions (or follow page 2 of the notification letter). If the User Test fails, the device will illuminate the Service indicator on the device. Please contact Physio-Control immediately to schedule the device correctio |
| Quantity | 338 units total (US =139 units; International = 199 units) |
| Distribution | Worldwide Distribution-US ( nationwide) in states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, VA, WA, WI, and WV and countries of: Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, French Guiana, Germany, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142430 | LIFEPAK 15 monitor/defibrillator Physio-Control, Inc., Dec 19, 2014 |