Recall Z-1691-2016 ยท IZL System, X-Ray, Mobile
Sedecal USA, Inc.
Sedecal SA Mobile Diagnost w DR x-ray system
| Date | Mar 23, 2015 |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111725 | MOBILEDIAGNOST WDR Sedecal., Sa., Jul 19, 2011 |