Reported Jan 16, 2019 · Terminated

Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed…

Siemens Medical Solutions USA, Inc.

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: Siemens Medical Solutions USA, Inc. · 2501 Barrington Rd · Hoffman Estates, IL · 60192-2061

Is this the product you have?

  • Siemens Biograph Horizon PET/CT System
  • Product UsageThe Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information
Lot codes and dates
  • Material Number

    108 of 108 codes

    • 10532746 - Serial #'s: 94401
    • 94405
    • 94406
    • 94408
    • 94409
    • 94413
    • 94414
    • 94415
    • 94420
    • 94421
    • 94422
    • 94423
    • 94424
    • 94425
    • 94426
    • 94427
    • 94429
    • 94430
    • 94431
    • 94432
    • 94433
    • 94434
    • 94435
    • 94436
    • 94438
    • 94440
    • 94441
    • 94442
    • 94443
    • 94444
    • 94445
    • 94447
    • 94448
    • 94451
    • 94452
    • 94457
    • 94459
    • 94460
    • 94461
    • 94462
    • 94463
    • 94464
    • 94466
    • 94467
    • 94473
    • 94476
    • 94477
    • 94480
    • 94481
    • 94482
    • 94483
    • 94484
    • 94485
    • 94487
    • 94491
    • 94492
    • 94493
    • 94495
    • 94496
    • 94497
  • and 94590 Material Number
    • 10532748 - Serial #'s: 94402
    • 94407
    • 94410
    • 94412
    • 94416
    • 94417
    • 94418
    • 94419
    • 94428
    • 94446
    • 94449
    • 94450
    • 94453
    • 94454
    • 94455
    • 94456
    • 94465
    • 94470
    • 94471
    • 94472
    • 94475
    • 94478
    • 94479
    • 94486
    • 94488
    • 94489
    • 94490
    • 94494
    • 94501
    • 94503
    • 94507
    • 94524
    • 94527
    • 94528
    • 94536
    • 94539
    • 94544
    • 94546
    • 94548
    • 94552
    • 94554
    • 94557
    • 94561
    • 94575
    • 94585
    • 94587
    • and 94593
Amount recalled
171

Where it was sold

Why it was recalled

Improper design or specifications.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 2, 2020 · Data as of Sep 19, 5:36 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.