Class 2 Device Recall HA FlexTrak

• Date Initiated by Firm: May 03, 2024
• Date Posted: June 04, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1950-2024
• Recall Event ID: 94603
• 510(K)Number: K213583
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
• Code Information: UDI: (01)00884838099500(21) Serial Numbers: 100018 100019 100020 100023 100024 100025 100026 100027 100028 100029 100030 100031 100032 100033 100034 100036 100038 100039 100041 100042 100043 100044 100045 100046 100047 100048 100049 100050 100051 100053 100054 100056 100057 100058 100059 100060 100062 100063 100064 100066 100067 100068 100069 100071 100072 100073 100074 100075 100076 100077 100078 100079 100080 100081 100083 100084 100085 100086 100087 100089 100090 100091 100092 100093 100094 100095 100096 100097 100098 100099 100100 100102 100103 100104 100105 100106 100107 100108 100109 100110 100111 100112 100113 100114 100115 100116 100117 100118 100119 100120 100121 100122 100123 100124 100125 100126 100127 100129 100130 100131 100133 100134 100135 100136 100137 100138 100140 100141 100143 100144 100145 100146 100148 100149 100150 100152 100153 100154 100155 100156 100157 100158 100159 100161 100164 100165 100166 100167 100170 100171 100172 100174 100175 100176 100177 100178 100179 100180 100181 100182 100183 100185 100186 100189 100190 100191 100192 100193 100194 100195 100197 100199 100200 100201 100202 100203 100204 100205 100206 100207 100209 100210 100211 100212 100213 100215 100216 100218 100220 100221 100222 100223 100224 100225 100226 100228 100232 100234 100235 100236 100237 100238 100239 100243 100244 100245 100246 100247 100248 100249 100250 100251 100252 100253 100254 100255 100256 100257 100258 100260 100262 100263 100264 100265 100266 100267 100268 100269 100271 100272 100273 100274 100275 100277 100278 100279 100282 100283 100284 100285 100287 100288 100289 100290 100291 100292 100293 100294 100295 100296 100297 100298 100299 100300 100301 100302 100303 100305 100306 100309 100310 100311 100312 100314 100316 100320 100322 100323 100324 100325 100326 100328 100329 100332 100336 100337 100339 100340 100342 100343 100345 100347 100351 100352 100353 100355 100356 100357 100358 100360 100361 100362 100363 100364 100366 100367 100368 100369 100370 100371 100372 100373 100374 100375 100376 100377 100378 100379 100380 100381 100383 100384 100385 100386 100387 100388 100389 100390 100392 100393 100394 100397 100399 100400 100401 100402 100404 100405 100407 100408 100409 100410 100411 100412 100413 100414 100415 100416 100418 100419 100420 100421 100423 100424 100425 100426 100427 100429 100430 100431 100432 100433 100434 100435 100436 100438 100440 100441 100442 100443 100444 100445 100446 100449 100450 100451 100452 100453 100454 100458 100459 100462 100465 100466 100468 100469 100471 100472 100473 100474 100475 100476 100477 100478 100479 100481 100482 100486 100487 100488 100489 100490 100491 100492 100493 100495 100496 100497 100498 100499 100500 100501 100502 100503 100504 100505 100506 100507 100509 100521 100526 100527 100528 100529 100530 100532 100533 100534 100539 100541 100547 100553 100554 100558 100561 100567 100569 100570 100571 100572 100573 100022 100052 100227 100230 100233 100242 100307 100308 100318 100321 100327 100330 100331 100341 100344 100348 100349 100350 100422 100463 100470 100480 100484 100494 100508 100511 100512 100513 100514 100515 100516 100517 100518 100519 100520 100522 100524 100525 100535 100536 100537 100538 100540 100542 100543 100545 100548 100549 100550 100551 100552 100555 100559 100560 100562 100563 100564 100565 100566 100568 100574 100575 100576 100578 100579 100580 100581 100582 100583 100584 100585 100586 100588 100589 100590 100591 100592 100594 100597 100598 100599 100600 100601 100602 100603 100604 100605 100606 100608 100609 100610 100612 100614 100615 100616 100619 100620 100622 100623 100624 100625 100626 100627 100628 100629 100630 100632 100633 100634 100635 100636 100637 100638 100639 100640 100641 100642 100643 100644 100645 100646 100647 100648 100649 100650 100651 100652 100653 100654 100655 100656 100657 100658 100659 100660 100661 100662 100665 100666 100667 100668 100669 100670 100674 100675 100680 100681 100683 100685 100688 100690 100691 100692 100695 100696 100697 100698 100699 100700 100701 100702 100703 100705 100706 100708 100709 100711 100714 100715 100718 100721 100725 100726 100727 100731 100732 100733 100734 100837
• 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: Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
• FDA Determined Cause: Under Investigation by firm
• Action: Philips NA issued URGENT Medical Device Correction letter to US consigneess dated May 3, 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: A. If you see hydraulic fluid (oil) leakage: " First remove fluid from the floor using a paper towel. Then remove any remaining oil film from the floor using a cleaning agent (e.g. soap and water) and paper towel. " Contact your local Philips service representative. B. You may continue to use your HA FlexTrak Trolley in accordance with the intended use. C. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm until this issue has been resolved. D. Please post this letter near the associated MR system(s) for ease of reference. E. Complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction, understanding of the issue, and required actions to be taken. A Philips representative will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the HA FlexTrack Trolley and correct if required (reference FCO78100580). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday).
• Quantity in Commerce: 590 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Fiji, Finland, France, French Guiana, Germany, Guadeloupe, Honduras, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, Oman, Peru, Poland, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, 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