Z-0251-2026 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
12 units

Product Description

Model Number 40KWFXPLUS-710CW, 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: G83204, G82622, G79677, G79194, G82129, G79632, G79837, G79924, G84490, G84640, G79699, G84605.