FDA Device recall Z-1435-2018
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5… 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-1435-2018 |
| 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
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 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 | (Added 6/25/18): 32550 22129 20226 21715 21558 21805 22134 13005 20027 21789 21264 21236 12078 20129 2163…(Added 6/25/18): 32550 22129 20226 21715 21558 21805 22134 13005 20027 21789 21264 21236 12078 20129 21639 20021 33037 21230 21231 20249 32171 21493 20149 8770 20154 32816 20173 20260 22096 21999 20050 20213 12074 21968 32508 21482 21688 39035 39005 21935 21572 20071 12100 12124 21891 39068 21609 22315 20106 39060 21998 32080 18673 21045 20331 22207 32500 32219 21099 8715 21351 21334 11024 8442 32085 8971 32084 22319 22286 21666 21693 32481 8165 21066 32003 8996 11027 33625 21930 21321 21798 20185 21776 22012 22167 12017 32344 21036 20321 20000 22089 21237 20282 32034 22245 11028 32131 39024 20257 21192 21957 21634 32616 21464 32346 20156 20065 21752 11052 21284 22001 11019 33675 10077 11094 21878 21328 21320 20236 20252 21070 20281 21479 20096 20126 21879 21976 21380 12061 21599 20204 20028 21681 11069 12021 12012 20161 32644 21304 13081 20141 32 |
|---|
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-1435-2018%22
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