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SEDECAL SA: Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system

Medical DevicesSource: FDA (device) · Date: 2025-10-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
SEDECAL SA
Product
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US: CA, IL, and NJ
Recall initiated
2025-06-10
Code info
UDI/DI 08436046001114, Serial Numbers: G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240.
Product quantity
9 units
Voluntary mandated
Voluntary: Firm initiated
City
Algete
Country
Spain
Event id
97075
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