Recall Z-1202-2023— SEDECAL SA

Name: FDA recall Z-1202-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-06

Class II · Ongoing

Class II FDA medical device recall by SEDECAL SA, initiated 2023-02-06. It names one FDA 510(k) clearance: K212291. Product: Phoenix mKDR, digital mobile diagnostic x-ray system. Reason: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems..

Recalling firm: SEDECAL SA
Classification: Class II
Status: Ongoing
Initiated: 2023-02-06
Firm location: Algete, N/A, Spain

510(k) clearances named in this recall

1 on FDA's record

K212291 — PHOENIXSedecal., Sa.·cleared 2021-09-14

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

Phoenix mKDR, digital mobile diagnostic x-ray system

Reason for recall

Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.

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