Philips North America Llc Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295 Recall
Severity assessment pending.
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Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
Brand
Philips North America Llc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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 30145 30064 30065 30123 30171 30085 30190 30226 30230 30231 30213 30135 30152 30155 30180 30181 30182 30183 30184 30185 30186 30187 30189 30220 30221 30223 30243 30250 30283 30310 30311 30017 30030 30047 30098 10193
Philips North America Llc is recalling Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a d due to 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 hospit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Philips issued Urgent Medical Device Correction notifications to customers on 22-Apr-2024 via FedEx . Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: If a smoke/fire alarm is detected: a. Immediately stop scanning and evacuate the patient and staff from the examination room. b. If a developing fire is detected, adhere to established hospital fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency Magnet Off button. c. Do not attempt to continue scanning. d. Immediately contact Philips Service. " Ensure all users are aware of facility specific Emergency Procedures as outlined in Chapter 2: Safety in the Instructions for Use Emergency procedures The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. " Post this notice near the affected MR system(s) for ease of reference. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt via email to: pd.cnr@philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. The actions planned by Philips to correct the problem Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit your site to inspect the g-MDU connections in the technical room and apply the proper torque to the connection if necessary.(reference FCO78100582). Philips plans t
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
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