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

Recall Z-0781-2024 — Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.

U.S. FDA — Device Enforcement · Spain · 2023-12-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0781-2024
Date of alert: 2023-12-13
Country / jurisdiction: Spain
Risk level: Class II
Risk type: recall
Brand: SEDECAL SA
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 08436046002500

Reported risk: Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.

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.

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.

Recall Z-0781-2024 — Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.

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