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SEDECAL SA: Model Number 40KWFXPLUS.005, 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 40KWFXPLUS.005, 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 08436046002166, Serial Numbers: G82576, G82871, G72391, G74872, G75722, G76782, G75035, G75723, G78884, G70532, G73630, G82077.
Product quantity
12 units
Voluntary mandated
Voluntary: Firm initiated
City
Algete
Country
Spain
Event id
97075
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