Recall Z-0182-2023— SEDECAL SA

Name: FDA recall Z-0182-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-12

Class II · Ongoing

Class II FDA medical device recall by SEDECAL SA, initiated 2022-08-12. It names one FDA 510(k) clearance: K192936. Product: Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500. Reason: Due to un-commanded movement of mobile x-ray unit..

Recalling firm: SEDECAL SA
Classification: Class II
Status: Ongoing
Initiated: 2022-08-12
Firm location: Algete, N/A, Spain

510(k) clearances named in this recall

1 on FDA's record

K192936 — Soltus 500Sedecal., Sa.·cleared 2019-11-15

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 Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

Reason for recall

Due to un-commanded movement of mobile x-ray unit.

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