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

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

Read the official notice at FDA (device) →

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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-B-D-C; 40KW 50G, 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 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.
Product quantity
39 units
Voluntary mandated
Voluntary: Firm initiated
City
Algete
Country
Spain
Event id
97075
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