Recall Z-2045-2023— SEDECAL SA

Name: FDA recall Z-2045-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-23

Class II · Ongoing

Class II FDA medical device recall by SEDECAL SA, initiated 2023-05-23. It names one FDA 510(k) clearance: K191813. Product: wDR 2.2 Mobile Digital Diagnostic X-Ray System. Reason: There is a software login in issue that may prevent the user from logging in..

Recalling firm: SEDECAL SA
Classification: Class II
Status: Ongoing
Initiated: 2023-05-23
Firm location: Algete, N/A, Spain

510(k) clearances named in this recall

1 on FDA's record

K191813 — MobileDiagnost wDR 2.2Sedecal., Sa.·cleared 2019-08-02

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

wDR 2.2 Mobile Digital Diagnostic X-Ray System

Reason for recall

There is a software login in issue that may prevent the user from logging in.

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