FDA recall Z-0255-2026

SEDECAL SA · Class II · device

Product

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.

Distribution

US: CA, IL, and NJ

Key facts

Status: Ongoing
Initiation date: 2025-06-10
Report date: 2025-10-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Algete, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0255-2026