Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Code No. 10532746, 10532748
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc.
- Reason for Recall:
- Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Product Codes/Lot Numbers:
Code No. 10532746, 10532748
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1930-2018
Related Recalls
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
ARTIS Pheno VE30A and VE40A, Model 10849000
Siemens Medical Solutions USA
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.