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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 Philipssee related information
Date Initiated by FirmMay 03, 2024
Date PostedMay 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1836-2024
Recall Event ID 94508
510(K)NumberK193215 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductAchieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
Code Information UDI-DI: (01)00884838004108(21) Serial Number 32307 33454 33668 32302 32401 32679 32699 32814 32894 32913 32923 32974 33002 33071 33073 33224 33227 33386 33387 33485 33488 33493 33502 33503 33518 33551 33571 33683 33704 33713 33746 32306 32475 33569 32075 32797 32326 33175 33519 33364 33702 32853 32100 32112 32186 32193 32216 32223 32243 32276 32277 32278 32301 32304 32339 32358 32367 32377 32484 32487 32493 32502 32565 32569 32570 32574 32598 32641 32655 32671 32695 32747 32782 32790 32843 32882 32893 32895 32897 32908 32912 32914 32945 32946 32959 32977 32981 32988 32995 33000 33011 33013 33055 33060 33064 33067 33074 33076 33101 33116 33118 33129 33134 33135 33136 33148 33184 33189 33190 33199 33225 33242 33244 33245 33254 33255 33275 33283 33286 33289 33293 33296 33305 33311 33330 33333 33335 33367 33370 33372 33388 33399 33402 33406 33408 33412 33414 33463 33478 33479 33480 33494 33526 33527 33539 33540 33541 33542 33543 33544 33545 33547 33549 33563 33564 33566 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33369 32192 32210 32272 32369 32371 32003 32034 32080 32083 32084 32085 32095 32171 32219 32226 32233 32314 32346 32351 32381 32388 32390 32424 32463 32474 32481 32500 32508 32517 32550 32581 32616 32644 32689 32712 32717 32739 32772 32792 32816 32966 33157 33625 32519 32795 33008 33009 33338 33516 33676 32917 33294 21447 32462 32810 32922 33043 33079 33109 33202 33464 33465 32711 (2) Serial Numbers: Serial Number 72018 72020 72104 72137 72138 72146 72157 72160 72170 72171 72179 72183 72185 72190 72200 72223 72233 72238 72251 72269 72013 72111 72112 72113 72231 72235 72270 72271 72272 72273 72315 72079 72083 72109 72120 72122 72123 72124 72126 72139 72140 72141 72142 72147 72150 72247 72007 72156 72101 72116 72117 72180 72197 72267 72189 72204 72325 72327 72008 72080 72036 72052 72057 72081 72103 72134 72143 72144 72145 72151 72186 72199 72217 72224 72227 72228 72236 72253 72254 72255 72256 72257 72258 72259 72260 72264 72278 72279 72296 72297 72298 72299 72304 72330 72029 72129 72153 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Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactCustomer 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
ActionPhilips 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 Commerce1585 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = LNH
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