FDA Device recall Z-1993-2016

LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed

FDA Device
Class II
terminated
Published 2016-06-22

On 2016-06-22 the FDA classified a Class II recall of LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed by Physio Control, citing 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 parti….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1993-2016
Classification	Class II
Status	terminated
Initiated	2016-01-27
Published	2016-06-22
Last updated	2026-09-13 11:54 UTC
Company	Physio Control
Distribution	US

Product

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/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

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.

Identifiers

code_info	*************SERIAL NUMBERS IN THE US ******************** 37241684, 37870230, 37870231, 37870232, 37870234, 378… ***********SERIAL NUMBERS IN THE US ********************** 37241684, 37870230, 37870231, 37870232, 37870234, 37870235, 37870237, 37870238, 37870240, 37870241, 37870242, 37870245, 37900601, 37923078, 37923079, 37923100, 37923153, 37923162, 37923203, 37923205, 37923208, 37923213, 37923214, 37924152, 37924153, 37928794, 37928964, 37930942, 37930944, 37930946, 37930962, 37930964, 37930966, 37930968, 37930977, 37930986, 37930987, 37930988, 37930990, 37930993, 37931003, 37933241, 37933244, 37933246, 37933249, 37933250, 37933254, 37933257, 37933262, 37933263, 37933267, 37933268, 37933271, 37933278, 37937842, 37937843, 37937846, 37937848, 37937849, 37937851, 37937854, 37937855, 37937856, 37937862, 37937863, 37937864, 37937865, 37937866, 37937867, 37937868, 37937870, 37937871, 37937872, 37937873, 37937874, 37937881, 37937885, 37937886, 37937887, 37937889, 37937891, 37937892, 37937894, 37937896, 37963292, 37963293, 37963295, 37963298, 37963299, 37963300, 37963302, 37963322, 37963323, 3796

code_info

***************SERIAL NUMBERS IN THE US ************************ 37241684, 37870230, 37870231, 37870232, 37870234, 378…

***************SERIAL NUMBERS IN THE US ************************ 37241684, 37870230, 37870231, 37870232, 37870234, 37870235, 37870237, 37870238, 37870240, 37870241, 37870242, 37870245, 37900601, 37923078, 37923079, 37923100, 37923153, 37923162, 37923203, 37923205, 37923208, 37923213, 37923214, 37924152, 37924153, 37928794, 37928964, 37930942, 37930944, 37930946, 37930962, 37930964, 37930966, 37930968, 37930977, 37930986, 37930987, 37930988, 37930990, 37930993, 37931003, 37933241, 37933244, 37933246, 37933249, 37933250, 37933254, 37933257, 37933262, 37933263, 37933267, 37933268, 37933271, 37933278, 37937842, 37937843, 37937846, 37937848, 37937849, 37937851, 37937854, 37937855, 37937856, 37937862, 37937863, 37937864, 37937865, 37937866, 37937867, 37937868, 37937870, 37937871, 37937872, 37937873, 37937874, 37937881, 37937885, 37937886, 37937887, 37937889, 37937891, 37937892, 37937894, 37937896, 37963292, 37963293, 37963295, 37963298, 37963299, 37963300, 37963302, 37963322, 37963323, 3796

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1993-2016%22

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