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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-0258-2026

June 10, 2025

Class II

Product summary

Firm
SEDECAL SA
Event
Event 97075
Status
Ongoing
Classification
Class II
Quantity
39 units
Official record key
device-enforcement:Z-0258-2026

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 08436046001510, Serial Numbers: G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643, G25673, G27664, G25708, G25689, G25457, C08042, G25641, G25663, G24234, G25517, G23833, G23945, G23954, G25458, G25528, G27497, G27497/584, G27651, G27689, G22586, G24220, G25755, G26016, G25529, G25396, G27792, C25709, G27701, G30684.

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.