The Recall Desk
HighFDA (Devices)·Z-0221-2015·Announced 2014-11-26

Elekta MOSAIQ Oncology System Recalled for Dose Rounding Error

Elekta, Inc. is recalling 15 units of the MOSAIQ oncology information system because a dose rounding error may cause incorrect numeric data to be displayed on printed reports.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for cancer treatment planning where a software error could lead to incorrect dose data. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Elekta, Inc. is recalling 15 units of the MOSAIQ oncology information system. MOSAIQ is used to manage workflows for treatment planning and delivery, supporting information flow among healthcare facility personnel where radiotherapy and/or chemotherapy are prescribed.

The recall is due to a problem that can result in the display of incorrect numeric data on printed reports caused by a dose rounding error. The affected software version is MOSAIQ Release 2.60.257.

The product was distributed nationwide in the United States, specifically in the states of Arizona, Colorado, Illinois, Maryland, Missouri, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, Texas, and Virginia. Healthcare facilities using this system should contact Elekta, Inc. for further instructions regarding the recall.

The recalled product

Product
MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Manufacturer
Elekta, Inc.
Category
Medical Device — Oncology Information System
Hazard
Affected units
15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • MOSAIQ Release 2.60.257

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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