FDA Device recall Z-0861-2026
IntelliVue Patient Monitor MX100
- FDA Device
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of IntelliVue Patient Monitor MX100 by Philips North America, citing potential issue where the IntelliVue monitors did not alarm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0861-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-31 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
IntelliVue Patient Monitor MX100. Product Number: 867033.
Reason
Potential issue where the IntelliVue monitors did not alarm.
Identifiers
| code_info | Product Number: 867033; UDI-DI: 00884838082595; All Serial No. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0861-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.