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Terminated

MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

FDA Recall Z-2063-2015 · Posted 2015-07-14

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-07-01
Date Terminated2021-09-15
Product Quantity74 Total (45 US)

Reason for Recall

A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.

Firm Action

Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-003 on July 1, 2015, to all affected customers. The notice informed users of the specific product and version numbers affected and that the problem only exists if all the following criteria is met - (1) Running Mosaiq 2.41; (2) with at least one linac equipped with an Agility 160 MLC head (Versa HD, Infinity, Axesse (EOS) or Synergy); and (3) who are treating with Stereotactic Cones. The notice also advises users of the workaround to avoid the problem. The customers were also instructed to return the Important Field Safety Notice Acknowledgment form. For questions regarding this recall call 770-670-2422.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, and Venezuela.

Official Source

View FDA Recall →

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

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