Recall Z-1633-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and indicates whether it detects a shockable rhythm. The LIFEPAK 500 AED requires operato
| Date | Apr 1, 2020 (initiated Mar 20, 2020) |
| Status | Terminated |
| Reason | Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment |
| Root cause | Device Design |
| Action | The firm is planning on providing consignees on March 20, 2020 with an "Urgent Medical Device Safety Notice & Correction" letter concerning the LIFEPAK 500 AED. In addition to informing consignees about the recalled device, the recall notifications requested consignees take the following action: If you experience a "CONNECT ELECTRODES" voice prompt with the LIFEPAK 500, immediately remove and reinstall the electrodes to the device or replace the electrodes with your spare electrodes and check patient connection. If CONNECT ELECTRODES" voice prompt continues, immediately obtain a backup dev |
| Quantity | 173,459 units |
| Distribution | Worldwide distribution - US Nationwide distribution and countries of Afghanistan, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Congo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012428 | MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Physio-Control Corp., Sep 28, 2001 |
| K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Emergency Response Systems, Inc., Feb 17, 2006 |
| K955854 | LIFEPAK 500 Physio-Control Corp., Nov 4, 1996 |
| K983393 | LIFEPAK 500 BIPHASIC Physio-Control Corp., May 5, 1999 |