Recall Z-2404-2019 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
| Date | Jul 31, 2019 |
| Status | Terminated |
| Reason | The injector holder could potentially fall off together with the injector and the storage box. |
| Root cause | Nonconforming Material/Component |
| Action | 1. Take special care when rotating the injector and storage box horizontally 2. Your Siemens Healthineers service engineer will perform an on-site check to evaluate the stability of the injector arm. 3. If there is any problem with the injector arm, your Siemens Healthineers service engineer will replace the injector arm with an improved intermediate version free of charge. 4. Please ensure all users of the affected products are aware. 5. Retain this notification in your product related records and place a copy in the medical device's instructions for use. 6. If you have distributed this |
| Quantity | 12 units |
| Distribution | US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO Siemens Medical Solutions USA, Inc., Apr 13, 2018 |