—#164139

Product

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

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K170904
Affected lot / code info: Software version VJ20A. Code No. 10532746, 10532748.

Why it was recalled

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 (FDA determination)

Software Design Change

Action the firm took

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 notice to the new owner.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60192-2061

Distribution

Distribution pattern: Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.

Timeline

Recall initiated: 2018-01-26
Terminated: 2018-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164139. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.