Skip to content
Recall Observatory FDA recall evidence

Device product

RADPRO MOBILE, Mobile X-ray system

Z-0281-2026

June 10, 2025

Class II

Product summary

Firm
SEDECAL SA
Event
Event 97075
Status
Ongoing
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-0281-2026

Official wording

Reason: 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.

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.

Distribution pattern: US: CA, IL, and NJ

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.