Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Philips

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-1839-2024
Recall Event ID 94508
510(K)Number K193215  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Achieva 3.0T
Model Number (REF):
(1) 781345;
(2) 781344;
(3) 781278;
(4) 781277;
(5) 781177
Code Information UDI-DI: (1) 781345 N/A; (2) 781344 N/A; (3) 781278 (01)00884838004139(21); (4) 781277 N/A; (5) 781177 N/A Serial Numbers: 24079 34231 34256 34289 34220 34308 34139 34200 34213 34255 34258 34276 34301 34306 34020 34052 34082 34113 34120 34123 34230 34234 34235 34239 34240 34247 34260 34264 34270 34272 34274 34285 34287 34288 34297 34298 34299 34309 34312 34056 34282 34023 34144 34228 24115 34001 34095 34138 34143 34165 34269 34293 34300 34305 34115 34225 34253 34038 34047 34077 34126 34135 34160 34206 34254 34268 34275 34118 34237 34271 34273 34291 34242 34261 34290 34033 34104 34281 34086 34106 34125 34159 34241 34263 34286 34294 34295 34311 34022 34043 34208 34109 34130 34203 34207 34304 34074 34028 34029 34030 34034 34065 34066 34071 34073 34085 34201 34011 38295 38074 38191 38247 38254 38276 38326 38346 38355 38363 38285 38043 38073 38087 38092 38098 38108 38124 38140 38152 38157 38158 38171 38181 38185 38189 38190 38194 38196 38206 38209 38210 38212 38215 38216 38227 38231 38233 38236 38238 38240 38245 38248 38249 38252 38255 38257 38258 38260 38264 38266 38267 38269 38270 38271 38279 38282 38284 38287 38292 38293 38298 38299 38303 38304 38307 38314 38318 38319 38320 38321 38324 38327 38328 38329 38330 38332 38335 38338 38339 38340 38343 38344 38347 38349 38351 38358 38360 38361 38367 38368 38370 38372 38401 38402 38405 38407 38408 38410 38412 38414 38415 38420 38421 38423 38424 38425 38426 38427 38429 38430 38431 38432 38433 38436 38437 38438 38439 38441 38442 38443 38445 38447 38448 38450 38453 38454 38456 38457 38458 38128 38288 38082 38174 38253 38044 38049 38079 38139 38141 38151 38167 38170 38188 38220 38228 38127 38145 38009 38034 38162 38251 38336 38354 38359 38055 38056 38278 38207 38021 38031 38054 38059 38061 38086 38095 38104 38115 38133 38137 38169 38186 38187 38193 38223 38237 38262 38273 38280 38313 38272 38322 38323 38337 38345 38200 38268 38090 38172 38265 38046 38150 38197 38217 38225 38261 38067 38130 38022 38047 38093 38241 38060 38138 38017 38064 38069 38112 38113 38143 38144 38154 38160 38205 38229 38234 38246 38256 38274 38291 38296 38297 38315 38331 38099 38003 38011 38078 38006 38057 38072 38085 38283 38302 38004 38016 38018 38033 38091 38103 38173 38341 38232 382320 73005 73008 73009 73002 73003 73004 73006 73010 74027 74034 74035 74041 74009 74004 74039 74047 74052 74001 74002 74010 74020 74026 74033 74046 74032 74005 74007 74021 74029 74030 74044 74048 74037
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 386 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 BV
-
-