Recall Z-1597-2018— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1597-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-26

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2018-01-26, terminated 2018-10-12. It names one FDA 510(k) clearance: K170904. 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..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-26
Terminated: 2018-10-12
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K170904 — Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.·cleared 2017-06-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.