LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The… — Class I medical device recall Z-0863-2019
Terminated recall by Physio-Control Inc, reported 2019-03-06. Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was d
| Recall number | Z-0863-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control Inc, Redmond, WA, United States |
| Recall initiated | 2019-02-01 |
| Classified | 2019-02-26 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2024-04-18 |
| Quantity | 682 kits |
| Serial numbers | 41271907, 41271908, 41271909, 41271910, 41271911, 41271932, 41271933, 41271934, 41271935, 41271936, 41271937, 41271940, 41271941, 41271942, 41271943, 41271944, 41271945, 41271946, 41271947, 41271948, 41271949, 41271950, 41271951, 41275459, 41275460 and 475 more |
Product
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 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
Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
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-0863-2019. 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.