Recall Z-1135-2023 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
| Date | Feb 13, 2023 (initiated Jan 16, 2023) |
| Status | Open, Classified |
| Reason | This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. |
| Root cause | Process control |
| Action | SIEMENS Healthineers distributed a Consumer Safety Advisory Notice to its consignees on 01/16/2023 by mail and email. The notice explained the issue and recommended that the following preventive actions be taken until a local Siemens Healthineers service representative has applied the correction: "Mitigation for Biograph Mobile Installations Ensure that the PET/CT Gantry offset protocol is performed every time the coach has moved. If the PET/CT gantry offset fails due to the results being out of tolerance, please cease clinical operations on the system and contact your local Siemens Health |
| Quantity | 6 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193248 | Biograph Vision, Biograph mCT Family of PET/CTs Siemens Medical Solutions USA, Inc., Feb 14, 2020 |