Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0247-2026 — Model Number 40KWFXPLUS.002, Mobile X-ray system

U.S. FDA — Device Enforcement · Spain · 2025-06-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0247-2026
Date of alert
2025-06-10
Country / jurisdiction
Spain
Risk level
Class II
Risk type
recall
Brand
SEDECAL SA
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08436046002166
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.