Recall Z-1930-2018 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
| Date | Feb 21, 2018 |
| Status | Terminated |
| Reason | Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module. |
| Root cause | Software design (manufacturing process) |
| Action | Customers were notified via letter on approximately 02/21/2018. Letters were sent via certified mail or email. Instructions included to discontinue use of the system (according to the cardiac imaging protocols listed in the letter), ensure the customer advisory notice is placed in the Biograph Horizon Operator's Manual, ensure the recall information is disseminated to all operators of the system, coordinate the installation of the updated Universal Physiological Measurement Module with Siemens Healthineers, and if the equipment has been sold to forward the letter to the new owner. |
| Quantity | 14 units |
| Distribution | Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170904 | Biograph Horizon PET/CT Siemens Medical Solutions USA, Inc., Jun 1, 2017 |