Siemens recalls Biograph Horizon PET/CT scanners with VJ20A software due to potential image distortion from improper PET QC phantom positioning. Affected units may require software updates or corrections to ensure accurate imaging.
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.
Siemens is recalling Biograph Horizon PET/CT scanners with VJ20A software because errors in PET image reconstruction can cause distortions. This affects scans used for medical diagnosis, where accurate imaging is critical for patient care.
The software error causes improper indexing of array values when creating norm files during quality control. This leads to image gradients that may distort PET scans. The severity depends on how the PET QC phantom is positioned relative to the scanner's center.
Medical facilities using Siemens Biograph Horizon PET/CT scanners with VJ20A software are most affected. Patients undergoing scans with these systems could experience inaccurate results if the software error occurs.
Check if your scanner has the VJ20A software version. Affected units were sold with software code numbers 10532746 or 10532748. The recall applies to specific medical imaging systems used in hospitals and clinics.
Verify your scanner's software version is VJ20A. If it is, contact Siemens for further instructions.
The recall addresses potential image distortion in scans, which could affect diagnostic accuracy. However, the risk is low and depends on specific scanner positioning during quality checks.
Check for software code numbers 10532746 or 10532748 on your scanner's system. Affected units use the VJ20A software version.
No immediate action is required. Contact Siemens to determine if your scanner needs correction or update.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1597-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1597-2018 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
