Class 2 Device Recall Ingenia Elition X

• Date Initiated by Firm: June 12, 2023
• Date Posted: August 11, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2395-2023
• Recall Event ID: 92720
• 510(K)Number: K173356 K173451 K183063 K193215 K213516
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
• Code Information: Product Number 781358: UDI-DI: 00884838088115; Serial Numbers: 45481 45476 45473 45470 45469 45467 45464 45463 45461 45459 45456 45451 45450 45448 45447 45446 45444 45443 45442 45441 45439 45438 45437 45435 45434 45432 45429 45428 45426 45423 45421 45419 45417 45416 45414 45412 45411 45410 45409 45408 45407 45406 45399 45398 45397 45396 45395 45394 45393 45392 45391 45390 45382 45381 45379 45378 45377 45376 45374 45372 45371 45370 45369 45368 45367 45364 45363 45362 45360 45359 45357 45356 45355 45354 45353 45352 45350 45349 45348 45345 45344 45343 45342 45340 45339 45338 45337 45335 45333 45332 45330 45328 45323 45322 45321 45320 45319 45317 45316 45315 45314 45313 45312 45311 45310 45309 45308 45307 45306 45305 45304 45303 45302 45300 45296 45295 45294 45293 45292 45290 45289 45284 45282 45281 45280 45279 45278 45277 45276 45274 45272 45269 45268 45267 45265 45264 45263 45262 45261 45260 45259 45257 45253 45252 45250 45249 45248 45247 45246 45245 45244 45243 45242 45241 45238 45237 45236 45235 45231 45229 45228 45227 45224 45222 45220 45219 45218 45217 45216 45215 45212 45211 45210 45207 45205 45204 45203 45197 45195 45194 45193 45192 45191 45190 45189 45188 45187 45186 45185 45184 45183 45181 45180 45179 45178 45177 45176 45174 45171 45170 45169 45168 45165 45164 45163 45162 45161 45160 45159 45158 45157 45156 45155 45154 45153 45152 45151 45150 45149 45148 45147 45146 45145 45144 45142 45141 45140 45139 45138 45137 45136 45134 45133 45132 45131 45129 45128 45127 45124 45123 45122 45121 45120 45119 45118 45116 45115 45114 45113 45112 45111 45109 45108 45107 45106 45105 45102 45100 45099 45098 45097 45096 45095 45094 45093 45092 45091 45090 45089 45088 45087 45086 45085 45084 45082 45081 45080 45079 45078 45077 45076 45075 45072 45071 45070 45068 45067 45066 45065 45064 45062 45061 45060 45058 45056 45055 45054 45053 45052 45051 45050 45049 45048 45047 45046 45045 45044 45043 45042 45041 45040 45039 45037 45036 45035 45034 45033 45032 45031 45030 45029 45028 45027 45026 45025 45024 45023 45011 45010 45009 45008 45001 45000 45002 45471 45073 45474 45480; Product Number 782107: UDI-DI: 00884838098336; Serial Numbers: 62147 62120 62091 62083 62082 62081 62080 62073 62071 62070 62056 62041 62040 62039 62038 62033 62031 62030 62027 62023 62021 62017 62016 62012 62011 45600 45599 45596 45595 45594 45589 45583 45580 45578 45577 45574 45573 45572 45570 45568 45567 45566 45565 45564 45563 45562 45561 45560 45559 45556 45555 45554 45552 45550 45547 45546 45545 45544 45543 45542 45540 45538 45536 45534 45533 45532 45531 45530 45528 45525 45524 45523 45521 45520 45519 45518 45517 45516 45514 45511 45510 45509 45508 45507 45506 45504 45503 45501 45500 62019 62024 62037 62042 62046 62088 62044 62035 62108 62118 62124 62134 62154 62164 62188 62173 62026 62054 62063 62148 62186 62051 62052 62061 62066 62113 62103 62111 62126 62114; Product Number 782118; UDI-DI: 00884838099746 Serial Numbers: 85661 71060 42054 42085 42113 42306 42329 71019 71025 42167 42194 71050; Product Number 782119: UDI-DI: 00884838104129; Serial Numbers: 66001 66002; Product Number 782136: UDI-DI: 00884838108608; Serial Numbers: 28509; Product Number 782151: UDI-DI: N/A; Serial Numbers: 26501
• Recalling Firm/ Manufacturer: Philips North America; 222 Jacobs St; Cambridge MA 02141-2296
• Manufacturer Reason for Recall: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT Medical Device Correction Notice dated 6/5/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users: 4.1. Philips has installed a SmokeDetector Interlock feature on all the systems listed in Appendix A. Post this notice near the affected MR system(s) for ease of reference. Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm until this issue has been resolved. Please complete and return the attached updated customer response form to Philips promptly and no later than 30 days from receipt of this letter. Philips is requesting that even if you acknowledged a previous version of this letter that you also respond with an acknowledgment to this updated letter. 4.2. The SmokeDetector Interlock feature is integrated with the MR System and powers off the relevant part of the system (Gradient Amplifier) when smoke is detected in order to prevent further development of smoke and/or fire. If the SmokeDetector Interlock has detected smoke and has powered off the Gradient Amplifier: Remove patient from the system according to the instructions for use because power to the tabletop will still be active Scanning is disabled until Philips service has checked the system. Do not attempt to continue scanning. Immediately inform Philips Service DO NOT attempt to restart or perform a power cycle of the system 4.3. If a user experiences smoke, fire, or severe image quality issues (image artifacts caused by electrical disturbances): Immediately stop scanning and evacuate the patient from the Examination Room. Check Examination Room for a developing fire. If a developing fire is sensed, adhere to established 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 Scanning is disabled until Philips service has checked t
• Quantity in Commerce: 640 total
• Distribution: US Nationwide. Global Distribution.
• 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; 510(K)s with Product Code = LNH; 510(K)s with Product Code = LNH