FDA Device recall Z-1691-2016
Sedecal SA Mobile Diagnost w DR x-ray system
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of Sedecal SA Mobile Diagnost w DR x-ray system by Sedecal Usa, citing 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" wa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1691-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-23 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sedecal Usa |
| Distribution | AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IN, KS, LA, MA, MD, ME, MI, MN, NC, NH, NJ, NY, OH, PA, TN, TX, UT, VT, WA, WI |
Product
Sedecal SA Mobile Diagnost w DR x-ray system
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.
Identifiers
| code_info | System Code 712001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1691-2016%22
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