Recall Z-0781-2024— SEDECAL SA

Name: FDA recall Z-0781-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Class II · Ongoing

Class II FDA medical device recall by SEDECAL SA, initiated 2023-12-13. It names one FDA 510(k) clearance: K012546. Product: 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.. Reason: Some parts have fallen off the equipment resulting in a safety risk to patients and/or users..

Recalling firm: SEDECAL SA
Classification: Class II
Status: Ongoing
Initiated: 2023-12-13
Firm location: Algete, N/A, Spain

510(k) clearances named in this recall

1 on FDA's record

K012546 — OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEMSedecal USA, Inc.·cleared 2001-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.