Class 2 Device Recall Philips

• Date Initiated by Firm: May 03, 2024
• Date Posted: May 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1849-2024
• Recall Event ID: 94508
• 510(K)Number: K193215
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
• Code Information: UDI-DI: (1) (01)00884838098312(21); (2) (01)00884838068452(21) Serial Number 78121 78150 78157 78096 78208 78094 78012 78074 78154 78161 78170 78171 78172 78173 78182 78183 78189 78190 78196 78198 78205 78210 78212 78213 78216 78218 78221 78225 78233 78235 78238 78240 78241 78242 78243 78244 78250 78251 78252 78253 78256 78257 78262 78263 78265 78266 78267 78268 78269 78270 78271 78272 78273 78279 78280 78281 78282 78283 78284 78288 78289 78291 78292 78293 78294 78295 78296 78301 78305 78306 78307 78308 78309 78310 78312 78313 78314 78316 78317 78319 78320 78321 78322 78323 78327 78328 78329 78330 78332 78333 78334 78335 78338 78339 78340 78341 78342 78343 78345 78346 78347 78352 78353 78354 78356 78357 78358 78359 78360 78361 78362 78363 78364 78366 78368 78370 78374 78375 78376 78377 78386 78078 78080 78224 78098 78003 78017 78065 78070 78076 78081 78087 78097 78099 78101 78104 78107 78126 78149 78151 78181 78206 78219 78264 23032 78063 78064 78106 78187 78000 78005 78007 78009 78010 78015 78016 78018 78019 78021 78023 78025 78027 78029 78031 78032 78033 78035 78038 78039 78040 78042 78043 78045 78048 78049 78050 78051 78062 78067 78068 78072 78082 78083 78084 78088 78089 78091 78095 78100 78109 78111 78113 78114 78115 78117 78127 78129 78132 78133 78139 78140 78145 78147 78148 78155 78199 78203 78207 78214 78222 78223 78004 78008 78053 78011 78013 78014 78028 78034 78044 78046 78047 78058 78060 78066 78071 78073 78075 78077 78086 78092 78102 78103 78110 78112 78118 78120 78122 78123 78128 78135 78137 78138 78141 78142 78158 78162 78164 78166 78167 78175 78180 78186 78188 78193 78194 78195 78197 78201 78202 78209 78215 78217 78227 78229 78232 78234 78239 78247 78254 78255 78259 78260 78261 78277 78286 78287 78290 78297 78298 78299 78324 78326 78336 78337 78030 78036 78059 78156 78249 78026 78022 78516 78517 78518 78519 78521 78522 78523 78524 78525 78526 78527 78528 78529 78530 78531 78536 78537 78539 78545 78546 78547 78548 78549 78550 78551 78553 78554 78556 78557 78559 78560 78561 78562 78564 78565 78567 78500 78501 78503 78504 78505 78507 78508 78512 78513 78532 78533 78535 78538 78540 78541 78542 78543 78544 78552 78566 78568
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Customer Care Solution Center; 800-722-9377
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 350 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LNH