Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI/DI 08436046001091, Serial Numbers: G23218
  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 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.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system

Product Codes/Lot Numbers:

UDI/DI 08436046001091, Serial Numbers: G23218

Distribution:

Distributed in: US, CA, IL, NJ

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0254-2026

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 →