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Z-0177-2019 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc. — Hoffman Estates, IL

FDA device recall Z-0177-2019 was initiated by Siemens Medical Solutions USA, Inc. on Sep 28, 2018 and is designated Class II. Reason for recall: The terminals on the plug may become loose and overheat. The recall status is terminated (terminated Feb 11, 2021). Affected quantity: 78 units.

Recall Details

Product Type: Devices
Report Date: Oct 24, 2018
Initiation Date: Sep 28, 2018
Termination Date: Feb 11, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 78 units

Product Description

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.

Reason for Recall

The terminals on the plug may become loose and overheat.

Distribution Pattern

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.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0177-2019
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.