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U.S. Department of Health and Human Services

Class 2 Device Recall Sedecal SA Mobile Diagnost w DR xray system

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  Class 2 Device Recall Sedecal SA Mobile Diagnost w DR xray system see related information
Date Initiated by Firm March 23, 2015
Create Date June 03, 2016
Recall Status1 Terminated 3 on March 09, 2018
Recall Number Z-1691-2016
Recall Event ID 74106
510(K)Number K111725  
Product Classification System, x-ray, mobile - Product Code IZL
Product Sedecal SA Mobile Diagnost w DR x-ray system
Code Information System Code 712001
Recalling Firm/
Manufacturer		 Sedecal USA, Inc.
230 Lexington Dr
Buffalo Grove IL 60089-6930
For Additional Information Contact
847-394-6960
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SEDECAL SA
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