Reported Aug 16, 2023 · Ongoing

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia…

Philips North America

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America · 222 Jacobs St · Cambridge, MA · 02141-2296

Is this the product you have?

  • Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Lot codes and dates
  • Product Number 781358UDI-DI: 00884838088115
  • Serial Numbers

    320 of 320 codes

    • 45481
    • 45476
    • 45473
    • 45470
    • 45469
    • 45467
    • 45464
    • 45463
    • 4546145459
    • 45456
    • 45451
    • 45450
    • 45448
    • 45447
    • 45446
    • 45444
    • 45443
    • 45442
    • 45441
    • 45439
    • 45438
    • 45437
    • 45435
    • 45434
    • 45432
    • 45429
    • 4542845426
    • 45423
    • 45421
    • 45419
    • 45417
    • 45416
    • 45414
    • 45412
    • 45411
    • 45410
    • 45409
    • 45408
    • 45407
    • 45406
    • 45399
    • 45398
    • 45397
    • 45396
    • 4539545394
    • 45393
    • 45392
    • 45391
    • 45390
    • 45382
    • 45381
    • 45379
    • 45378
    • 45377
    • 45376
    • 45374
    • 45372
    • 45371
    • 45370
    • 45369
  • Product Number 782107UDI-DI: 00884838098336
  • Serial Numbers

    90 of 90 codes

    • 62147
    • 62120
    • 62091
    • 6208362082
    • 62081
    • 62080
    • 62073
    • 62071
    • 62070
    • 62056
    • 62041
    • 62040
    • 62039
    • 62038
    • 62033
    • 62031
    • 62030
    • 62027
    • 62023
    • 62021
    • 62017
    • 6201662012
    • 62011
    • 45600
    • 45599
    • 45596
    • 45595
    • 45594
    • 45589
    • 45583
    • 45580
    • 45578
    • 45577
    • 45574
    • 45573
    • 45572
    • 45570
    • 45568
    • 45567
    • 4556645565
    • 45564
    • 45563
    • 45562
    • 45561
    • 45560
    • 45559
    • 45556
    • 45555
    • 45554
    • 45552
    • 45550
    • 45547
    • 45546
    • 45545
    • 45544
    • 45543
    • 45542
    • 4554045538
    • 45536
    • 45534
    62044; Product Number 782118
  • UDI-DI00884838099746
  • Serial Numbers
    • 85661
    • 71060
    • 42054
    • 42085
    • 42113
    • 42306
    • 42329
    • 71019
    • 71025
Amount recalled
601 Total

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.