Z-0281-2026 Class II Ongoing

Recalled by SEDECAL SA — Algete

Recall Details

Product Type
Devices
Report Date
October 29, 2025
Initiation Date
June 10, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 units

Product Description

RADPRO MOBILE, 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 Pattern

US: CA, IL, and NJ

Code Information

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.