Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI/DI 08436046002593, Serial Numbers: G-81478, G81924, G84618, G87981, G88006, G88007, G87866, G84607, G86618, G88041, G87427, G80991, G-81936, G86688, G-82904, G86360, G84340, G86372, G81471, G86358, G86361, G87844, G87845, G85932, G86683, G84620, G84621, G85914, G87409, G87434, G84326, G84325, G-81925, G81923, G-81935, G84619, G-81934, G87426, G81002, G86686, G84339, G88042, G-82885, G-82887, G-82905, G84327, G85788, G85913, G85801, G86356, G87867, G88008, G87425, G86659, G88009, G87846.
  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:

Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

Product Codes/Lot Numbers:

UDI/DI 08436046002593, Serial Numbers: G-81478, G81924, G84618, G87981, G88006, G88007, G87866, G84607, G86618, G88041, G87427, G80991, G-81936, G86688, G-82904, G86360, G84340, G86372, G81471, G86358, G86361, G87844, G87845, G85932, G86683, G84620, G84621, G85914, G87409, G87434, G84326, G84325, G-81925, G81923, G-81935, G84619, G-81934, G87426, G81002, G86686, G84339, G88042, G-82885, G-82887, G-82905, G84327, G85788, G85913, G85801, G86356, G87867, G88008, G87425, G86659, G88009, G87846.

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-0242-2026

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 →