Z-1597-2018 Class II Terminated
FDA device recall Z-1597-2018 was initiated by Siemens Medical Solutions USA, Inc. on Jan 26, 2018 and is designated Class II. 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… The recall status is terminated (terminated Oct 12, 2018). Affected quantity: 42 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Jan 26, 2018
- Termination Date
- Oct 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 units
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.
Distribution Pattern
Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.
Code Information
Software version VJ20A. Code No. 10532746, 10532748.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1597-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026