Recall Z-0178-2019 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j)
| 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 | 890 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
| K173578 | Biograph mCT Family of PET/CT Systems Siemens Medical Solutions USA, Inc., Dec 20, 2017 |