Sedecal USA, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1691-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Sedecal SA Mobile Diagnost w DR x-ray system

Product Classification:

Class II

Date Initiated: March 23, 2015

Date Posted: June 15, 2016

Recall Number: Z-1691-2016

Event ID: 74106

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.

Status: Terminated

Product Quantity: US - 145

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.

Voluntary or Mandated:

Voluntary: Firm initiated