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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm May 03, 2024
Date Posted May 17, 2024
Recall Status1 Open3, Classified
Recall Number Z-1850-2024
Recall Event ID 94508
510(K)Number K213583  K193215  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Ingenia Ambition S
Model Number (REF):
(1) 782139;
(2) 782133;
(3) 782108;
(4) 781359
Code Information UDI-DI: (1) 782139 (01)00884838108639(21); (2) 782133 N/A; (3) 782108 (01)00884838098343(21); (4) 781359 (01)00884838090057(21) Serial Numbers: Serial Number 48016 48053 48126 48003 48136 48285 48144 48020 48030 48124 48155 48191 48216 48218 48245 48300 48183 48186 48187 48222 48225 48234 48240 48241 48249 48269 48278 48284 48288 48293 48294 48299 48304 48313 48317 48326 48331 48051 48223 48207 48028 48031 48049 48050 48131 48134 48154 48160 48242 48254 48219 48000 48004 48005 48009 48019 48032 48132 48145 48224 48244 48040 48122 48039 48022 48152 48173 48012 48014 48036 48037 48044 48127 48151 48158 48174 48184 48043 48046 48047 48055 48128 48129 48153 48178 48180 48190 48192 48194 48226 48275 48181 48198 48199 48200 48023 48033 48045 48001 48038 48167 48185 48196 48236 48238 48239 48034 48276 48010 48170 48035 48172 48027 48248 48146 48147 48148 48163 48164 48165 48169 48182 48188 48271 48291 48297 48302 48303 48308 48309 48310 48329 48018 48283 48177 48011 48017 48056 48250 48272 48253 48268 48013 48015 48052 48112 48120 48130 48162 48166 48171 48179 48214 48217 48233 48237 48243 48252 48273 48274 48286 48287 48314 48026 48322 48133 48316 48558 48572 48566 48581 48592 48652 48800 48893 48544 48506 48520 48521 48534 48551 48712 48714 48715 48810 48813 48833 48883 48885 48538 48539 48602 48613 48650 48501 48502 48507 48514 48530 48540 48568 48569 48577 48579 48580 48590 48591 48614 48620 48629 48632 48638 48641 48503 48606 48660 48529 48609 48622 48541 48549 48616 48504 48508 48513 48524 48536 48537 48555 48560 48571 48573 48585 48593 48594 48597 48600 48522 48561 48564 48668 48726 48519 48532 48533 48505 48510 48567 48604 48515 48584 48512 48582 48647 48850 48610 48615 48500 48523 48535 48546 48552 48554 48562 48575 48578 48586 48637 48645 48648 48656 48525 48526 27500 27502 27504 27505 27506 27507 27508 27509 27511 27512 27514 27515 27516 27517 27518 27519 27520 27522 27523 27524 27525 27526 27527 27528 27529 27530 27531 27532 27533 27535 27536 27539 27541 27542 27543 27544 29021 29000 29010 29011 29012 29014 29017 29018 29025 29003 29006 29009 29015 29023 29013 29027 29005 29019
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 2		 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 328 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 and Original Applicant = Philips Medical Systems Nederland B.V.
510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland BV
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