Class 2 Device Recall Siemens Biograph Horizon

• Date Initiated by Firm: September 28, 2018
• Create Date: October 18, 2018
• Recall Status: Terminated on February 11, 2021
• Recall Number: Z-0177-2019
• Recall Event ID: 81144
• 510(K)Number: K170904
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: 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.
• 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
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 2501 Barrington Rd; Hoffman Estates IL 60192-2061
• For Additional Information Contact: 847-304-7700
• Manufacturer Reason for Recall: The terminals on the plug may become loose and overheat.
• FDA Determined Cause: Process control
• 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
• Quantity in Commerce: 78 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS and Original Applicant = Siemens Medical Solutions USA, Inc.