Recall Z-2248-2018 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc.
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by compu
| Date | Jun 8, 2018 (initiated May 29, 2018) |
| Status | Terminated |
| Reason | Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems. |
| Root cause | Device Design |
| Action | The firm notified the consignees of the issue by email on May 29, 2018. The letter identified the affected product, problem and actions to be taken. They are tracking completion of the letter delivery through the hand-delivered approach. For further questions, please call (847) 304-7700. . |
| Quantity | 405 units |
| Distribution | Worldwide Distribution |
| 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 |