LIFEPAK 15 Monitor — Class I medical device recall Z-1123-2017
Terminated recall by Physio-Control, Inc., reported 2017-02-22, distributed nationwide. The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to del
| Recall number | Z-1123-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2017-01-12 |
| Classified | 2017-02-10 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2017-09-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BR, CA, CZ, DE, DK, FI, FR, GB, IE, IL, IN, IT, JP, LT, LU, LV, MY, NL, NO, NZ, PL, QA, SA, SE, SI, TR, ZA |
| Serial numbers | 42701550, 42702539, 42730815, 42738872, 42800549, 42803986, 42862109, 42884428, 42944609, 42989327, 43022460, 43040692, 43048791, 43066974, 43116838, 43116994, 43119477, 43132954, 43133203, 43133221, 43133906, 43154308, 43154457, 43156695, 43161425 and 313 more |
Product
LIFEPAK 15 Monitor, Automated External Defibrillator (AED), 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 has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA).
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-1123-2017. 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.