Sedecal SA Mobile Diagnost w DR x-ray system
FDA Recall Z-1691-2016 · Posted None
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Recalling FirmSedecal USA, Inc.
Recall StatusTerminated
Product CodeIZL
Date Initiated2015-03-23
Date Terminated2018-03-09
Product QuantityUS - 145
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.
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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