Sedecal SA Mobile Diagnost w DR x-ray system — Class II medical device recall Z-1691-2016
Terminated recall by Sedecal USA, Inc., reported 2016-06-15, distributed in AR, AZ, CA, CT, DE, FL, GA, HI…. Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult
| Recall number | Z-1691-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sedecal USA, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2015-03-23 |
| Classified | 2016-06-03 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2018-03-09 |
| Distributed | 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 |
| Quantity | 145 |
| Reason classes | software |
Product
Sedecal SA Mobile Diagnost w DR x-ray system
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1691-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.