Elekta Recalls MOSAIQ Oncology Information System Due to Data Saving Error
Elekta is recalling 47 MOSAIQ Oncology Information System units because edits to particle field definition parameters may not be saved.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 data integrity error could lead to incorrect treatment parameters. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 47 units of the MOSAIQ Oncology Information System. This software is used to manage workflows for treatment planning and delivery, supporting information flow among healthcare facility personnel where radiotherapy and chemotherapy are prescribed.
The recall was initiated because edits to Particle field definition parameters may not be saved when the field definition window is saved. This defect could potentially impact the accuracy of treatment planning data.
The affected units are versions 2.60 and higher. The products were distributed nationwide in the United States to Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas, and Virginia, as well as internationally to Italy, Japan, South Korea, Sweden, and the United Kingdom. Healthcare facilities should contact Elekta for further instructions on how to address this issue.
The recalled product
- Product
- MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
- Manufacturer
- Elekta, Inc.
- Affected units
- 47
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)
- Versions 2.60 an higher
Distribution
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