Recall Z-1993-2016 · MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/d
| Date | Jun 15, 2016 (initiated Jan 27, 2016) |
| Status | Terminated |
| Reason | The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 value. This affects all LIFEPAK 15 with an EtC02 feature installed and configured to the kPa or % setting. |
| Root cause | Software design |
| Action | Physio-Control sent the letter with the title Information Regarding LIFEPAK 15 MONITOR/DEFIBRILLATOR WITH End-tidal CO2 OPTION, dated January 2016, to customers in the United Kingdom (UK) as REQUESTED by the Medicines and Healthcare product Regulatory Agency (MHRA) on January 27, 2016. Physio initiated a voluntary field action on February 23, 2016 and started notifying US consignees on March 22, 2016 and started notifying international consignees on April 18, 2016. The Information Regarding LIFEPAK 15 MONITOR/ DEFIBRILLATOR WITH End-tidal CO2 OPTION letter, dated March 2016, was sent. Custo |
| Quantity | 44798 units total (23189 units in US; 21609 units international) |
| Distribution | Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142430 | LIFEPAK 15 monitor/defibrillator Physio-Control, Inc., Dec 19, 2014 |