FDA Device recall Z-1440-2018
T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device 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-1440-2018 |
| 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
T10-NT, Model 78107 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): 4170 4113 4082 4176 4147 4319 4397 4285 4308 4408 4241 4064 4328 4312 4294 4296 4009…(Added 6/25/18): 4170 4113 4082 4176 4147 4319 4397 4285 4308 4408 4241 4064 4328 4312 4294 4296 4009 4274 4258 4297 4246 4200 4041 4207 4327 4318 4089 4102 4222 4025 4321 4177 4015 4088 4106 4260 4183 4272 4416 4365 4047 4411 4254 4301 4261 4307 4267 4386 4033 4099 4251 4339 4374 4162 4322 4320 4069 4006 4273 4418 4131 4194 4201 4152 4146 4095 4391 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1440-2018%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.