Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
- Recall Initiated
- June 10, 2025
- Posted
- October 23, 2025
- Recall Number
- Z-0264-2026
- Quantity
- 27 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.
Distribution
US: CA, IL, and NJ
Lot / Code Info
UDI/DI unknown, Serial Numbers:G31761, G30761, G32587, G32577, G31065, G33581, G30808, G30762, G29873, G30156, G30173, G30952, G30689, G33004, G30155, G30025, G35450, G35620, G30570, G31077, G29426, G33144, G29416, G30160, G30685, G33723, G30165.
Root Cause
Device Design
Action Taken
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.