Recall Z-1597-2018 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc.
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
| Date | Jan 26, 2018 |
| Status | Terminated |
| Reason | Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image. The severity of the error is directly related to the positioning of the PET QC phantom relative to the center of the field of view. |
| Root cause | Software Design Change |
| Action | Customers were notified via letter on approximately 01/26/2018. Instructions included to ensure proper positioning of the PET QC Phantom when performing the PET Quality Control Procedure by following section 6.3.1 in the Biograph Horizon Operator's Manual for Examination and Acquisition, complete the software update to PETsyngo VJ20B, ensure the recall notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of the Biograph Horizon. If the equipment has been sold to another customer, they are instructed to provide the recall |
| Quantity | 42 units |
| Distribution | Worldwide distribution. US nationwide, Australia, France, India, Japan, and 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 |