Recall Z-1425-2017 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA Inc.
Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and Produce cross-sec
| Date | Feb 28, 2017 (initiated Feb 20, 2017) |
| Status | Terminated |
| Reason | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. |
| Root cause | Labeling Change Control |
| Action | Siemens sent a Customer Advisory Notice letter on February 20, 2017 to affected customer. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens. |
| Quantity | 4 units |
| Distribution | Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141971 | BIOGRAPH TRUE PET/CT FAMILY SOFTWARE Siemens Medical Solutions USA, Inc., Sep 12, 2014 |