FDA Device recall Z-1597-2018
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner by Siemens Medical Solutions Usa, citing 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 reconstru….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1597-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-26 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
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.
Identifiers
| code_info | Software version VJ20A. Code No. 10532746, 10532748. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1597-2018%22
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