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Open, Classified

MOSAIQ Oncology Information System

FDA Recall Z-2293-2016 · Posted None

Recalling FirmElekta, Inc.
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2016-07-15
Product Quantity383

Reason for Recall

It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.

Firm Action

Elekta sent Important Field Safety Notice 371-03-MSQ-001 to all customers on 7/15/2016. 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. The letter also included a response form which is to be returned to Elekta.

Root Cause

Software Design Change

Distribution Pattern

Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123230MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc. · 2012-12-12

Official Source

View FDA Recall →

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

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