LIFEPAK15 monitor/defibrillator with End-Tidal C02 — Class II medical device recall Z-1993-2016
Terminated recall by Physio-Control, Inc., reported 2016-06-22, distributed nationwide. The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is ab
| Recall number | Z-1993-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2016-01-27 |
| Classified | 2016-06-15 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BB, BE, BH, BR, CA, CH, CL, CN, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, GY, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, KY, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PA, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, UA, ZA |
| Serial numbers | 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 and 475 more |
| Model numbers | V15-2-XXXXXX |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1993-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.