Elekta Recalls MOSAIQ Oncology System Due to Dosage Calculation Error
Elekta, Inc. is recalling 399 units of the MOSAIQ Oncology Information System because a software issue with age and weight data can cause incorrect drug dosages.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of incorrect drug dosage, which is a significant injury risk.
Plain-English summary
Elekta, Inc. is recalling 399 units of the MOSAIQ Oncology Information System, a software system used to manage workflows for treatment planning and delivery in radiotherapy and chemotherapy. The recall is due to a software issue involving "Age Limit" and patient weight data items that can result in incorrect drug dosages.
The affected software includes versions 2.50 and higher. The units were distributed nationwide in the United States and in several international countries, including Australia, Canada, Germany, and the United Kingdom. The recall is classified as Class II by the FDA.
Healthcare facilities using the MOSAIQ system should contact Elekta, Inc. for instructions on how to resolve the issue and ensure patient safety.
The recalled product
- Product
- 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.
- Manufacturer
- Elekta, Inc.
- Affected units
- 399
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 2.50 and higher
Distribution
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