Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1691-2016 — Sedecal SA Mobile Diagnost w DR x-ray system

U.S. FDA — Device Enforcement · United States · 2015-03-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1691-2016
Date of alert
2015-03-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sedecal USA, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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