Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
- Recall Initiated
- June 10, 2025
- Posted
- October 23, 2025
- Recall Number
- Z-0263-2026
- 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.
Distribution
US: CA, IL, and NJ
Lot / Code Info
UDI/DI 08436046001510, Serial Numbers: G32487, 31414, G35462, G32657.
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.