Jun

2016

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Sedecal SA Mobile Diagnost w DR x-ray

Amy Sellers

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