Cl II Sedecal SA Mobile Diagnost w DR x-ray

Company: Sedecal USA, Inc.
Date of Enforcement Report 6/15/2016
Class lI:

PRODUCT

Sedecal SA Mobile Diagnost w DR x-ray system.
Recall Number Z-1691-2016

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/MANUFACTURER
Sedecal USA, Inc., Buffalo Grove, IL on 3/23/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
145

DISTRIBUTION
Nationwidewide

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