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Recall Observatory FDA recall evidence

Device product

Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system

Z-0278-2026

June 10, 2025

Class II

Product summary

Firm
SEDECAL SA
Event
Event 97075
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0278-2026

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: G39544, G62558, G71736, G40116, G65568, G65570.

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.