Recall Z-1691-2016— Sedecal USA, Inc.

Name: FDA recall Z-1691-2016
Creator: U.S. Food and Drug Administration
Published: 2015-03-23

Class II · Terminated

Class II FDA medical device recall by Sedecal USA, Inc., initiated 2015-03-23, terminated 2018-03-09. It names one FDA 510(k) clearance: K111725. Product: Sedecal SA Mobile Diagnost w DR x-ray system. Reason: Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface..

Recalling firm: Sedecal USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Terminated: 2018-03-09
Firm location: Buffalo Grove, IL, United States

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

Sedecal SA Mobile Diagnost w DR x-ray system

Reason for recall

Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface.

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