Recall Z-1083-2024— SEDECAL SA

Name: FDA recall Z-1083-2024
Creator: U.S. Food and Drug Administration
Published: 2021-10-14

Class II · Ongoing

Class II FDA medical device recall by SEDECAL SA, initiated 2021-10-14. It names 3 FDA 510(k) clearances: K191813, K141895, K111725. Product: MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007. Reason: While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion..

Recalling firm: SEDECAL SA
Classification: Class II
Status: Ongoing
Initiated: 2021-10-14
Firm location: Algete, N/A, Spain

510(k) clearances named in this recall

3 on FDA's record

K191813 — MobileDiagnost wDR 2.2Sedecal., Sa.·cleared 2019-08-02
K141895 — MOBILEDIAGNOST WDRSedecal., Sa.·cleared 2014-09-18
K111725 — MOBILEDIAGNOST WDRSedecal., Sa.·cleared 2011-07-19

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

MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

Reason for recall

While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

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