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Open, Classified

MOSAIQ Oncology Information System

FDA Recall Z-2591-2021 · Posted None

Recalling FirmElekta, Inc.
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2021-09-02
Product Quantity31

Reason for Recall

A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.

Firm Action

The recalling firm issued an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" dated August 2021 via email to its consignees on 9/2/2021. Recommendations were made to the user until a fix is available.

Root Cause

Software design

Distribution Pattern

Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183034MOSAIQ Oncology Information SystemElekta, Inc. · 2018-12-04

Official Source

View FDA Recall →

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

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