FDA Device recall Z-1842-2024
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 7812…
- FDA Device
- Class II
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 7812… by Philips North America, citing the g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resultin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1842-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-03 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
Reason
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Identifiers
| code_info | UDI-DI: N/A Serial Numbers: 35062 35028 35068 35081 35055 35069 35084 35024 35025 35070 35007 35013 35064 35071 35083…UDI-DI: N/A Serial Numbers: 35062 35028 35068 35081 35055 35069 35084 35024 35025 35070 35007 35013 35064 35071 35083 35022 35063 35074 35049 35035 35067 35004 35006 35011 35015 35016 35021 35050 35057 35061 35075 35076 35082 35085 |
|---|
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-1842-2024%22
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