Recall Z-0893-2022 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
| Date | Mar 11, 2022 |
| Status | Terminated |
| Reason | There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue. |
| Root cause | Nonconforming Material/Component |
| Action | Customer Advisory Notice Letter will be provided to each impacted consignee. Depending on the customer s capabilities, Siemens provides the letters via mail, e-mail, or hand delivery by a service engineer. The receipt of the letter will be documented, and additional attempts will be made until such receipt is acknowledged. The safety advisory letter informs customers: You may continue to use your system ensuring to follow all instructions in the Operator Manual. If any changes in system vibrations or noises are detected, then activate the Emergency Stop (E-Stop), discontinue use of the sys |
| Quantity | 7 devices |
| Distribution | Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200474 | Symbia 6.7 Siemens Medical Solutions USA, Inc., Mar 20, 2020 |