Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial # 82044; 82105; 82070; 82054; 82040;82038;82065 82108; 82010; 82039; 82109 82102 82066
- 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:
- The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
Product Codes/Lot Numbers:
Serial # 82044; 82105; 82070; 82054; 82040;82038;82065 82108; 82010; 82039; 82109 82102 82066
Distribution:
Distributed in: US, AR, MO, NY, IN, TX, NC, PA, MI, LA, WA, CA, AL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0614-2018
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