Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1597-2018.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1597-2018.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1597-2018.
Siemens Medical Solutions USA, Inc.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Siemens Medical Solutions Usa, Inc. Recall FAQ
Siemens Medical Solutions Usa, Inc. is the subject of a diagnostic devices safety report: Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.. The notice was published on January 26, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 42 units are potentially affected.