Z-1691-2016Class II

Sedecal SA Mobile Diagnost w DR x-ray system

Name: Z-1691-2016 Sedecal SA Mobile Diagnost w DR x-ray system
Creator: Sedecal USA, Inc.
Published: 2015-03-23
License: https://open.fda.gov/license/

Sedecal USA, Inc / initiated 2015-03-23 / Terminated / root cause: software

FDA source

Sedecal USA, Inc. began a recall of Sedecal SA Mobile Diagnost w DR x-ray system on 2015-03-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1691-2016
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Posted: 2016-06-03
Terminated: 2018-03-09
Recalling firm: Sedecal USA, Inc
Product: Sedecal SA Mobile Diagnost w DR x-ray system
Product code: IZL System, X-Ray, Mobile
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.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Sedecal USA has developed a new software release to address this issue. The distributor of this product, Philip, will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and initiate a software update to correct the two defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (847) 394-6960.
Quantity in commerce: US - 145
Distribution: 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.
Product codes and lots: System Code 712001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1691-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1691-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-03

Product code IZL

K111725Class IIMobilediagnost WdrSedecal., Sa. / cleared 2011-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)