HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR…
Medical device recall Z-1948-2024. Published in FDA’s Enforcement Report on Jun 12, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 12, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1348 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
1348 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: N/A Serial Numbers: 3 5 6 9 11 12 13 14 15 16 17 18 19 20 22 23 25 26 29 30 31 32 33 34 35 37 38 39 41 42 43 44 45 49 50 51 52 53 55 56 58 61 63 64 66 67 68 70 71 72 73 75 77 79 80 81 82 83 84 86 87 88 89 91 93 94 95 97 98 100 101 102…
Every code shown here, 2,000 characters
UDI: N/A Serial Numbers: 3 5 6 9 11 12 13 14 15 16 17 18 19 20 22 23 25 26 29 30 31 32 33 34 35 37 38 39 41 42 43 44 45 49 50 51 52 53 55 56 58 61 63 64 66 67 68 70 71 72 73 75 77 79 80 81 82 83 84 86 87 88 89 91 93 94 95 97 98 100 101 102 103 104 105 107 108 109 110 111 112 113 114 115 116 117 118 119 120 122 123 124 125 126 129 130 132 133 135 136 137 138 139 140 141 142 143 146 148 149 150 151 152 153 154 155 156 158 159 160 161 162 163 164 165 167 169 170 171 172 173 174 175 177 180 181 183 184 185 186 188 189 190 191 192 193 195 196 197 198 200 201 202 203 204 205 206 207 208 209 211 212 213 215 216 218 219 220 221 222 223 224 225 226 228 229 232 233 234 235 236 237 238 240 241 242 243 244 246 248 250 251 253 254 255 257 258 259 260 262 263 264 265 267 269 270 272 273 274 275 278 279 281 282 284 286 287 288 289 290 291 292 293 294 295 296 297 298 301 302 303 304 305 307 308 309 310 311 312 313 314 315 317 318 319 320 322 323 324 325 326 328 331 332 334 335 336 337 338 339 340 341 342 343 344 345 346 347 350 351 352 355 356 358 359 360 361 362 363 364 366 367 368 369 370 371 372 373 374 375 379 380 381 382 384 386 387 388 390 391 392 394 395 396 397 399 400 401 402 403 404 405 406 408 409 411 412 413 414 415 416 417 419 420 421 422 423 424 426 427 428 429 431 432 434 435 436 437 438 439 440 441 442 444 445 446 448 449 450 451 452 453 454 456 457 460 461 462 463 464 465 466 467 468 469 472 473 474 475 476 477 478 479 480 481 482 483 485 487 489 491 492 493 494 496 497 498 499 500 501 502 503 504 506 507 508 509 510 511 512 515 516 517 518 520 522 523 524 525 528 529 531 532 534 535 536 537 538 541 542 543 544 545 546 547 548 549 550 552 553 554 555 556 558 559 560 561 562 564 565 566 567 568 569 571 574 575 577 579 582 583 584 585 587 588 591 592 593 594 596 597 598 599 600 601 603 605 607 608 609 610 611 613 614 618 619 620 621 623 625 627 628 629 630 631 633 634 635 639 640 641 642 643 645 646 647 648 650 651 652 653 656 658 659 660 661 662 663 664 665 666 667…
FDA’s list runs to 5,992 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 3, 2024.
- FDA classified it on Jun 4, 2024.
- FDA’s Enforcement Report published it on Jun 12, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, of Cambridge, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,992 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.