Phoenix mKDR Xpress, digital mobile diagnostic x-ray system

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI/DI 08436046003163, Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
SEDECAL SA
Reason for Recall:
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Phoenix mKDR Xpress, digital mobile diagnostic x-ray system

Product Codes/Lot Numbers:

UDI/DI 08436046003163, Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1203-2023

Related Recalls

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Jun 10, 2025 Other Medical Devices View Details →