FDA Device recall Z-0105-2015
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A
- FDA Device
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 the FDA classified a Class II recall of Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A by Philips Medical Systems, citing philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0105-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-03 |
| Published | 2014-10-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
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
Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Identifiers
| code_info | software revision J.30.58: |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0105-2015%22
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