Philips IntelliVue Monitors with software revisions J — Class II medical device recall Z-0104-2015
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-0104-2015 |
|---|---|
| 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 | 7,587 units |
Product
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
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-0104-2015. 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.