MOSAIQ oncology software may fail to load adapted treatment plan
The MOSAIQ Oncology Information System is being recalled because the software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.
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: FDA Class II recall where a radiotherapy plan may fail to load during treatment delivery, a risk of harm with no injuries reported in the source.
Plain-English summary
The MOSAIQ Oncology Information System, software version MOSAIQ 3.2, UDI 07340201500071, is being recalled. The action covers 12 programs.
The stated reason is that the software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs. The FDA classified the action as Class II.
Distribution was worldwide, including within the United States in Wisconsin, Florida, Louisiana, New York and New Jersey among other states. The system is installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected installations using the software version and UDI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- MOSAIQ Oncology Information System
- Manufacturer
- Elekta, Inc.
- Affected units
- 12
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)
- Software Version: MOSAIQ 3.2/UDI: 07340201500071
Distribution
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