Recall Z-1660-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
| Date | May 23, 2014 (initiated May 9, 2014) |
| Status | Terminated |
| Reason | Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100 |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On May 9, 2014 Physio-Control sent an Urgent Medical Device Recall Letter (dated May 2014) to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customer notification letter will provide new instructions on how to check the functional and power readiness of the device and advise the customer on the actions to take based on the symbol displayed. Customers are asked to record the readiness indicator(s) shown on each device and fax the confirmation sheet back to Physio-Control at 1-866-448-9567. Customers are also direc |
| Quantity | 96,611 units total (40,974 in the US and 55,637 outside the US) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA AND HERZOGOVENIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CANARY ISLANDS, CAYMAN ISLANDS, CHILE, China, COLOMBIA, COSTA RICA, CROATIA, Curacao, CYP |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042404 | LIFEPAK, MODEL 1000 Medtronic Emergency Response Systems, Inc., Dec 22, 2005 |