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Recall Observatory FDA recall evidence

Device product

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

Z-1597-2020

September 24, 2019

Class II

Product summary

Firm
Elekta Impac Software
Event
Event 85240
Status
Ongoing
Classification
Class II
Quantity
3732 units
Official record key
device-enforcement:Z-1597-2020

Official wording

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

Code information: Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305); MOSAIQ 2.20 (00858164002312); MOSAIQ 2.30 (00858164002329); MOSAIQ 2.40 (00858164002077); MOSAIQ 2.41 (00858164002084); MOSAIQ 2.60 -2.64 (00858164002091); MOSAIQ 2.50 (00858164002107); MOSAIQ 2.65 (00858164002220); MOSAIQ 2.70 (00858164002037); MOSAIQ 2.80 (00858164002251); MOSAIQ 2.81 (00858164002282)

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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