Recall Z-1257-2017 · MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
| Date | Mar 3, 2017 (initiated Jan 13, 2017) |
| Status | Terminated |
| Reason | The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage. |
| Root cause | Device Design |
| Action | Physio Control sent an Urgent Medical Device Correction letter dated January 2017 to all affected customers. The firm issued the press release on January 13, 2017. The link to press release is http://www.fda.gov/Safety/Recalls/ucm537114.htm. The firm also started mailing letter, confirmation sheet, check list to consignees on January 13, 2017. On August 28, 2017, the US begun contacting customers that have not yet responded to the previous mailings. Information about this notice is available at: www.physio-control.com/lifepak1000-274. Customers were instructed to immediately remove a |
| Quantity | total 133,330 units (50,046 units in the US) |
| Distribution | Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122600 | LIFEPAK 1000 DEFIBRILLATOR Physio-Control, Inc., Oct 11, 2012 |