Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number GMR40. Serial numbers 00001 through 00016.
- 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:
- NeuroLogica Corporation
- Reason for Recall:
- While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Product Codes/Lot Numbers:
Model Number GMR40. Serial numbers 00001 through 00016.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1391-2018
Related Recalls
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
GM60A. Digital Diagnostic Mobile X-Ray System.
NeuroLogica
Potential for the anti-fall system of the device arm to fail.
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.