PlainRecalls
FDA Devices Moderate Class II Ongoing

Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system

Reported: October 29, 2025 Initiated: June 10, 2025 #Z-0255-2026

Product Description

Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system

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.

Details

Recalling Firm
SEDECAL SA
Units Affected
8 units
Distribution
US: CA, IL, and NJ
Location
Algete

Frequently Asked Questions

What product was recalled?
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system. Recalled by SEDECAL SA. Units affected: 8 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 29, 2025. Severity: Moderate. Recall number: Z-0255-2026.