SEDECAL SA recalls Model Number SM-40HF-B-D-C

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.

Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

Sedecal emailed their distributors on 06/10/2025 to remind them 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. on 09/19/2025 the firm issued an Important Safety Notice to its direct consignees via email. This notice initiates Phase 2 of the recall strategy expanding the scope and providing information on stickers to cover gaps around the fine positioning control buttons and a DMC software update that stops unit movement if triggered by a short cicuit or prolonged button press with instructions. Consignees will be contacted by a Sedecal Customer support Service to coordinate the shipment of the necessary conversion kits (quantity and delivery address) to allow upgrading the affected units.

• FDA enforcement recordOfficial FDA database entry for Z-0258-2026
• FDA 510(k) clearance · K090322The device's official FDA premarket clearance record
• FDA device classification · IZLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1720The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SEDECAL SASearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.