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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-1851-2024
Recall Event ID 94508
510(K)Number K213583  K193215  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF):
(1) 782138;
(2) 782109;
(3) 781356
Code Information UDI-DI: (1) 782138 (01)00884838108622(21); (2) 782109 (01)00884838098350(21); (3) 781356 (01)00884838090040(21); Serial Number 47194 47040 47092 47091 47048 47195 47345 47361 47050 47209 47246 47247 47293 47254 47275 47019 47049 47200 47356 47357 47197 47270 47013 47014 47015 47053 47065 47082 47099 47268 47274 47000 47002 47003 47017 47020 47024 47035 47047 47056 47058 47074 47078 47089 47097 47192 47225 47337 47226 47227 47341 47307 47364 47365 47372 47284 47350 47057 47075 47081 47088 47174 47175 47188 47193 47288 47052 47059 47072 47085 47184 47187 47211 47252 47262 47304 47328 47342 47384 47064 47244 47219 47220 47298 47094 47329 47096 47207 47283 47190 47264 47309 47034 47202 47315 47332 47367 47385 47016 47269 47382 47352 47012 47021 47221 47276 47297 47313 47314 47271 47281 47001 47032 47041 47248 47255 47258 47301 47311 47272 47306 47009 47023 47030 47080 47083 47189 47215 47222 47230 47231 47242 47245 47286 47299 47302 47310 47312 47004 47006 47007 47011 47018 47022 47025 47026 47027 47028 47029 47033 47037 47038 47039 47043 47044 47045 47051 47054 47060 47061 47062 47063 47066 47067 47068 47070 47071 47084 47090 47093 47095 47098 47177 47183 47185 47196 47198 47199 47203 47204 47205 47206 47208 47210 47216 47233 47237 47251 47253 47260 47278 47279 47280 47282 47289 47290 47291 47292 47294 47303 47305 47316 47322 47323 47324 47325 47330 47331 47333 47335 47336 47338 47339 47340 47344 47346 47347 47348 47351 47353 47370 47371 47377 47378 47380 47387 47173 47077 47657 47866 47531 47540 47878 47612 47717 47518 47519 47523 47526 47552 47555 47573 47584 47839 47565 47644 47742 47585 47582 47885 47669 47748 47755 47507 47508 47505 47570 47610 47500 47527 47529 47545 47640 47725 47778 47855 47532 47533 47547 47548 47591 47831 47843 47882 47607 47583 47625 47626 47627 47628 47629 47630 47675 47676 47786 47509 47525 47765 47848 47517 47504 47579 47683 47688 47737 47784 47808 47810 47812 47511 47520 47536 47543 47553 47561 47562 47564 47634 47646 47671 47681 47694 47698 47706 47708 47751 47603 47623 47705 47578 47516 47841 47502 47716 47754 47782 47783 47649 47656 47798 47665 47557 47589 47834 47876 47550 47790 47513 47602 47528 47770 47804 47860 47883 47785 47791 47874 47549 47635 47512 47648 47674 47696 47747 47806 47807 47864 47535 47588 47614 47615 47617 47651 47652 47660 47661 47662 47663 47709 47710 47711 47718 47720 47721 47722 47723 47724 47727 47728 47729 47730 47731 47780 47781 47851 47884 47503 47560 47530 47546 47563 47680 47685 47697 47811 47845 47566 47597 47679 47695 47753 47577 47701 47738 47514 47521 47522 47539 47559 47594 47595 47596 47622 47632 47666 47667 47677 47678 47684 47792 47801 47534 47538 47541 47542 47554 47558 47567 47568 47569 47572 47574 47575 47576 47580 47590 47598 47599 47606 47608 47621 47642 47653 47654 47659 47668 47672 47682 47687 47692 47700 47702 47703 47726 47732 47733 47739 47740 47759 47761 47762 47763 47767 47771 47789 47794 47796 47799 47800 47802 47814 47815 47816 47820 47824 47835 47849 47859 47861 47862 47888 47609 49004 49000 49091 49019 49062 49015 49044 49045 49052 49053 49058 49071 49054 49013 49047 49001 49002 49003 49066 49008 49009 49010 49064 49097 49017 49057
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 509 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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