Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

MOSAIQ Oncology Information System

FDA Recall Z-2052-2016 · Posted None

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2016-06-17
Date Terminated2020-08-18
Product Quantity69

Reason for Recall

It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.

Firm Action

Elekta sent an Important Field Safety Notice to all customers on June 17, 2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. A software patch will be issued for Mosaiq version 2.62 in order to the correct the defect. For further questions please call (404) 993-5886.

Root Cause

Software design

Distribution Pattern

US Distribution including Puerto Rico and to the states of : AK, AZ, CA, FL, GA, IL, IN, LA, MD, MI, MO, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and to the countries of : Canada, Denmark, Finland, Germany, Israel, Japan, Netherlands, Norway, Sweden, United Kingdom

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑