CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report

Biograph Horizon a) 3R, Material Number 10532746 b) 4R recalled

Siemens Medical Solutions USA is recalling Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The, distributed nationwide in the US. The recall was initiated on 28 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 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

Quantity recalled78 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0177-2019
FDA event ID: 81144
Recalling firm: Siemens Medical Solutions USA, Hoffman Estates, IL
Classification: Class II
Status: Terminated
Recall initiated: 28 Sep 2018
FDA classified: 18 Oct 2018
Reported: 24 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

28 Sep 2018	Recall initiated by company
18 Oct 2018	Classified by FDA	+20 days
24 Oct 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The terminals on the plug may become loose and overheat.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Brunnel, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Republic Korea, Lebanon, Sri Lanka, Macedonia, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, Switzerland, Thailand, Turkey, Taiwan, UAE, United Kingdom and Vietnam.

Nationwide

Questions about this recall

Is Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The recalled?

Yes. Siemens Medical Solutions USA recalled Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The on 28 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0177-2019.

Why was it recalled?

The terminals on the plug may become loose and overheat.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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