FDA Device recall Z-1433-2018
Intera 1.5T
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Intera 1.5T 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-1433-2018 |
| 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
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise
Reason
Potential risk for helium gas inside the MR examination room during a magnet quench
Identifiers
| code_info | (Added 6/25/18): 8920 8590 8368 8210 10049 8277 10039 10087 8302 18629 8050 18749 10777 8699 18554 8250…(Added 6/25/18): 8920 8590 8368 8210 10049 8277 10039 10087 8302 18629 8050 18749 10777 8699 18554 8250 8073 8540 18050 10691 18784 8056 10198 8244 8583 8889 18079 8408 10031 8052 8899 8234 10137 18974 10014 8612 8916 10133 8928 10789 18966 10118 10195 8009 8846 8668 8797 10092 10732 8233 18034 8003 18723 8418 8934 10111 8536 8268 8462 10727 30047 8893 10721 10221 8670 8216 18667 30098 8721 8569 8666 10010 18860 8691 8888 8898 8975 8080 10729 8198 8963 18030 8872 18578 8037 8788 18549 10167 8043 10097 8951 8544 8432 8626 8655 18579 8316 8744 10005 8482 8827 8856 8403 10695 8320 18725 10707 10144 8836 8995 18110 18025 18031 9011 10105 10722 10724 8184 8176 10786 10100 8366 8112 8301 10697 8772 10217 18100 8255 8141 8414 8436 18728 8585 8101 8332 10677 8841 10726 10693 8019 8850 8269 18642 18065 18750 10803 8631 8937 9034 18093 18662 8818 |
|---|
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-1433-2018%22
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