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Terminated

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.

FDA Recall Z-0177-2019 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2018-09-28
Date Terminated2021-02-11
Product Quantity78 units

Reason for Recall

The terminals on the plug may become loose and overheat.

Firm Action

The firm, Siemens Healthineers, disseminated the " Customer Safety Advisory Notice" on 09/28/2018 to its customers. The notice described the product, problem and actions to be taken. The notice stated the potential problem and how to identify it. The customers were instructed to do the following: in the event overheating occurs or notice a distinct burning odor; stop use of your system and contact Siemens Healthineers service representatives.The issue will be addressed through a service visit to check if the terminal screws are torqued to the proper specification. If you have any questions, please contact your local Siemens Healthineers service representatives at the following numbers: America: 1-800-888-7436 Europe, Middle East, and Africa: +49 9131 940 4000 Asia and Australia: +86(21)3811 2121

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170904Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2017-06-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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