SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number of device 10762471with serial numbers: 5043 5085 5069 5086 5037 5072 5049 5039 5120
- 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:
- Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Product Codes/Lot Numbers:
Model Number of device 10762471with serial numbers: 5043 5085 5069 5086 5037 5072 5049 5039 5120
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1668-2015
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