SEDECAL SA: Device Recall

Recall #Z-0270-2026 · 06/10/2025

Class II: Risk

Recall Details

Recall Number: Z-0270-2026
Classification: Class II
Product Type: Device
Recalling Firm: SEDECAL SA
Status: Ongoing
Date Initiated: 06/10/2025
Location: Algete, Spain
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4 units

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.

Product Description

Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system

Distribution Pattern

US: CA, IL, and NJ

Other Recalls by SEDECAL SA

Class II: Risk 06/10/2025

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.
Class II: Risk 06/10/2025

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.
Class II: Risk 06/10/2025

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.
Class II: Risk 06/10/2025

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.
Class II: Risk 06/10/2025

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.

View all recalls by SEDECAL SA →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.