FDA Device recall Z-1853-2024
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
- FDA Device
- Class II
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device 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-1853-2024 |
| 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
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
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 Number: 30199 30200 30201 30062 30191 30240 30241 30242 30305 30315 30125 30088 30113 30222 30252…UDI-DI: N/A Serial Number: 30199 30200 30201 30062 30191 30240 30241 30242 30305 30315 30125 30088 30113 30222 30252 30268 30028 30038 30058 30069 30081 30095 30100 30117 30118 30138 30164 30167 30168 30169 30170 30192 30197 30207 30209 30217 30228 30246 30248 30249 30256 30262 30267 30281 30284 30289 30297 30298 30306 30307 30312 30314 30210 30219 30245 30254 30276 30029 30043 30052 30061 30083 30101 30107 30114 30115 30116 30119 30120 30122 30130 30137 30140 30153 30154 30158 30159 30160 30163 30173 30174 30177 30178 30179 30196 30203 30251 30253 30259 30265 30266 30277 30279 30280 30282 30285 30291 30293 30104 30105 30216 30244 30290 30308 30316 30070 30208 30102 30112 30133 30206 30214 30224 30238 30261 30264 30274 30295 30303 30051 30084 30149 30215 30227 30232 30233 30234 30235 30035 30055 30143 30148 30272 30288 30294 8281 30304 30142 30218 30109 30131 30063 30091 30094 30202 30059 30099 30175 30176 30198 30237 30263 30269 30270 30302 30309 8002 8143 8122 8855 8404 30053 30075 |
|---|
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-1853-2024%22
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