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Recall Observatory FDA recall evidence

Device product

Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

Z-0264-2026

June 10, 2025

Class II

Product summary

Firm
SEDECAL SA
Event
Event 97075
Status
Ongoing
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-0264-2026

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 unknown, Serial Numbers:G31761, G30761, G32587, G32577, G31065, G33581, G30808, G30762, G29873, G30156, G30173, G30952, G30689, G33004, G30155, G30025, G35450, G35620, G30570, G31077, G29426, G33144, G29416, G30160, G30685, G33723, G30165.

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.