Recall Z-2100-2016 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
| Date | May 25, 2016 |
| Status | Terminated |
| Reason | LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. |
| Root cause | Component change control |
| Action | The firm, Physio Control, sent an "URGENT MEDICAL DEVICE CORRECTION-ACTION REQUIRED"- LifePak CR Plus AE and LifePak Express AED letter and the Confirmation sheet, dated May 2016, to US customers on 5/25/16. Physio will notify international consignees during the week of 6/13/16. The letter described the product, problem and the actions to be taken. The customers were instructed to-URGENTLY bring this letter to the immediate attention of the person(s) responsible for maintaining/monitoring your Automated External Defibrillators (AEDs); follow the instructions on the Confirmation Sheet that ou |
| Quantity | 25178 units (10,418 in US and 14,760 outside US) |
| Distribution | Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and countries of: Argentina, Austria, Australia, Bahamas, Bangladesh, Belgium, Brazil, Brunei Darussalami, Canada, Chile, China, Croatia, Cyprus. Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Icela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033275 | LIFEPAK 12, 20, 500, CR PLUS Medtronic Physio-Control Corp., Nov 6, 2003 |