Recall Z-0177-2019 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
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.
| Date | Sep 28, 2018 |
| Status | Terminated |
| Reason | The terminals on the plug may become loose and overheat. |
| Root 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170904 | Biograph Horizon PET/CT Siemens Medical Solutions USA, Inc., Jun 1, 2017 |