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Recall Observatory FDA recall evidence

Device product

Sedecal SA Mobile Diagnost w DR x-ray system

Z-1691-2016

March 23, 2015

Class II

Product summary

Firm
Sedecal USA, Inc.
Event
Event 74106
Status
Terminated
Classification
Class II
Quantity
US - 145
Official record key
device-enforcement:Z-1691-2016

Official wording

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.

Code information: System Code 712001

Distribution pattern: US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ, GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN, CT, ID, MI, AR and KS.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software defect