Recall Z-1040-2015— Sedecal S.A.

Name: FDA recall Z-1040-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-06

Class II · Terminated

Class II FDA medical device recall by Sedecal S.A., initiated 2014-08-06, terminated 2016-06-22. It names one FDA 510(k) clearance: K111725. Product: MobileDiagnost wDR motorized portable diagnostic X-ray systems.. Reason: Reports of unexpected movement..

Recalling firm: Sedecal S.A.
Classification: Class II
Status: Terminated
Initiated: 2014-08-06
Terminated: 2016-06-22
Firm location: Algete, N/A, Spain

510(k) clearances named in this recall

1 on FDA's record

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 motorized portable diagnostic X-ray systems.

Reason for recall

Reports of unexpected movement.

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