Reported Oct 24, 2018 · Terminated

Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and…

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?

  • Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT 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
  • a)
  • Material Number 10532746 Serial Numbers
    • 94427
    • 94405
    • 94408
    • 94445
    • 94463
    • 94401
    • 94432
    • 94415
    • 94421
    • 94429
    • 94436
    • 94440
    • 94448
    • 94464
    • 94464
    • 94466
    • 94476
    • 94484
    • 94406
    • 94430
    • 94434
    • 94451
    • 94483
    • 94485
    • 94409
    • 94413
    • 94414
    • 94420
    • 94422
    • 94423
    • 94424
    • 94425
    • 94426
    • 94431
    • 94435
    • 94438
    • 94441
    • 94442
    • 94443
    • 94444
    • 94452
    • 94459
    • 94460
    • 94473
    • 94477
    • 94480
    • 94481
    • 94482
    • 94487
    • 94433
    b)
  • Material Number 10532748 Serial Numbers
    • 94500
    • 94449
    • 94454
    • 94470
    • 94404
    • 94417
    • 94428
    • 94465
    • 94472
    • 94478
    • 94456
    • 94419
    • 94471
    • 94410
    • 94412
    • 94418
    • 94446
    • 94453
    • 94475
    • 94479
    • 94416
    • 94455
    • 94486
    • 94450
    • 94411
    • 94402
    • 94407
    • 94489
Amount recalled
78 units

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

The terminals on the plug may become loose and overheat.

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

Notice updated Feb 11, 2021 · Data as of Sep 19, 4:50 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.