Sedecal SA Mobile Diagnost w DR x-ray system recall: Software Issue
Sedecal SA Mobile Diagnost w DR x-ray system
Why was Sedecal SA Mobile Diagnost w DR x-ray system recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
System Code 712001
- Product
- Sedecal SA Mobile Diagnost w DR x-ray system
- Recalling firm
- Sedecal USA, Inc.
- Quantity
- 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.
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)