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Open, Classified

MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.

FDA Recall Z-1597-2020 · Posted 2020-03-26

Recalling FirmElekta Impac Software
Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2019-09-24
Product Quantity3732 units

Reason for Recall

The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.

Firm Action

The firm began notifying their consignee on 09/24/2019 by email. The notice explained the issue and provided a workaround for the consignee to use until the updated software is ready for release.

Root Cause

Software design

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

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

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