Artis pheno- Model No. 10849000
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 04056869046877 Serial Numbers 164766 164140 164138 164287 164740 164210 164183 164184 164776 164312 164071 164034 164391 164763 164306 164735 164277 164095 164072 164771 164743 164048 164741 164241 164186 164069 164213 164728 164263 164060 164113 164398 164366 164279 164774 164074 164084 164086 164098 164153 164330 164389 164394 164772 164718 164163 164297 164778 164333 164377 164397 164300 164105 164227 164022 164250 164739 164703 164187 164211 164100 164097 164775 164303 164352 164726 164724 164760 164371 ***Updated 9/23/22*** 164794 164400 ***Updated 1/9/23*** 164793 164172 164795
- 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:
- Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
- 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- Model No. 10849000
Product Codes/Lot Numbers:
UDI-DI: 04056869046877 Serial Numbers 164766 164140 164138 164287 164740 164210 164183 164184 164776 164312 164071 164034 164391 164763 164306 164735 164277 164095 164072 164771 164743 164048 164741 164241 164186 164069 164213 164728 164263 164060 164113 164398 164366 164279 164774 164074 164084 164086 164098 164153 164330 164389 164394 164772 164718 164163 164297 164778 164333 164377 164397 164300 164105 164227 164022 164250 164739 164703 164187 164211 164100 164097 164775 164303 164352 164726 164724 164760 164371 ***Updated 9/23/22*** 164794 164400 ***Updated 1/9/23*** 164793 164172 164795
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1646-2022
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.
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