Recall Z-1858-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portable external defibrillator with monitor used by healthcare providers in EMS, hospital and clinic settings. The LIFEPAK 12 has both manual and semi-automatic defibrillation operations. When clinically indicated, the LIFEPAK 12 defibrillator/monitor allows the operator to deliver a
| Date | Sep 11, 2008 (initiated May 8, 2008) |
| Status | Terminated |
| Reason | The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. |
| Root cause | Process control |
| Action | Starting May 8, 2008, letters were hand-delivered by the firm's service representatives as they visited customer sites to perform on-site service for affected units. Customers who had not been visited by May 16th were mailed a Certified Receipt letter on May 16, 2008. The letter explained the recall and notified customers that Physio Control was conducting a Field correction to replace all affected Biphasic PCBA. The firm recommends customers continue to perform therapy cable or Standard Paddles Defibrillation Check (monthly or as needed); to have a backup device available until their devi |
| Quantity | 1,710 Units |
| Distribution | Product distributed nationwide to 5 Department of Defense accounts, 1 VA account, 5 government accounts, 49 hospitals, 223 first responders, and 1 direct account. 8 foreign accounts include: NETHERLANDS, MEXICO, JAPAN, HONG KONG, GERMANY, CANADA and AUSTRALIA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991910 | LIFEPAK 12 BIPHASIC Physio-Control Corp., Sep 3, 1999 |