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

MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system — recall Z-0243-2026

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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0243-2026
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)
08436046002357
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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.