Philips Avalon Monitors with software revision J — Class II medical device recall Z-0105-2015
Terminated recall by Philips Medical Systems, Inc., reported 2014-10-29, distributed nationwide. Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic m
| Recall number | Z-0105-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-10-03 |
| Classified | 2014-10-21 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2017-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, CH, CN, CO, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, KR, NG, NI, NL, NO, NZ, OM, PL, RO, RU, SE, SG, SI, TH, TR, TW, UA, ZA |
| Quantity | 118 units |
Product
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
Reason for recall
Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
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-0105-2015. 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.