FDA Device recall Z-0854-2016
Philips IntelliVue Module Measurement X2 Model: M3002A
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Philips IntelliVue Module Measurement X2 Model: M3002A by Philips Electronics North America, citing the ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0854-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-04 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
Philips IntelliVue Module Measurement X2 Model: M3002A
Reason
The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor
Identifiers
| code_info | Software Revision: K.21.54 or L.00.96 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0854-2016%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.