Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number: 164719 164712 164740 164722 164763 164735 164723 164743 164741 164728 164711 164718 164739 164703 164721 164726 164724 164725 164760 UDI: 04056869046877
- 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:
- Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Product Codes/Lot Numbers:
Serial Number: 164719 164712 164740 164722 164763 164735 164723 164743 164741 164728 164711 164718 164739 164703 164721 164726 164724 164725 164760 UDI: 04056869046877
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0987-2022
Related Recalls
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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
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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
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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.