Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers 1) Luminos Agile Max, Material #10762472, UDI/DI: 4056869009162 2) Luminos drF Max, Material #10762471, UDI/DI: 4056869009155 3) Luminos Lotus Max, Material #11574100, UDI/DI: 4056869269331
- 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:
- There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Product Codes/Lot Numbers:
All serial numbers 1) Luminos Agile Max, Material #10762472, UDI/DI: 4056869009162 2) Luminos drF Max, Material #10762471, UDI/DI: 4056869009155 3) Luminos Lotus Max, Material #11574100, UDI/DI: 4056869269331
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1002-2023
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