FDA Device recall Z-1441-2018
Multiva systems
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Multiva systems by Philips Electronics North America, citing potential risk for helium gas inside the MR examination room during a magnet quench.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1441-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-16 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Reason
Potential risk for helium gas inside the MR examination room during a magnet quench
Identifiers
| code_info | None |
|---|
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-1441-2018%22
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