RADPRO MOBILE, Mobile X-ray system
- Recall Initiated
- June 10, 2025
- Posted
- October 23, 2025
- Recall Number
- Z-0281-2026
- Quantity
- 24 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 08436046002166, Serial Numbers: G30567, G31256, G32581, G30250, G28320, G30902, G29864, G35389, G30960, G33238, G31252, G33708, G30771, G33634, 31412, 31480, G33004, G33112, G33585, G31271, G31285, G32514, G32498, G35665.
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.