Recall Z-0999-2017 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA Inc.
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 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 computer reconstruction of X-Ray tran
| Date | Jan 10, 2017 (initiated Dec 13, 2016) |
| Status | Terminated |
| Reason | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Root cause | Device Design |
| Action | Siemens Healthineers sent a Customer Safety Advisory Notice letter on December 13, 2016. The letter states that the light marker windows used for the positioning laser and integrated into the front cover of the Biograph mCT or Biograph mCT Flow system may loosen and potentially drop out and warning the consignee not to use the system of the front cover is loose or missing. Customers with questions were instructed to contact their local Siemens representative at the following numbers: America 1-800-888-7436 Europe, Middle East and Africa +49 9131 940 4000 Asia and Australia +86 (21) 3811 21 |
| Quantity | 1 unit |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151486 | Biograph mCT and mCT Flow PET/CT Scanners Siemens Medical Solutions USA, Inc., Jul 17, 2015 |