[pending] MOSAIQ Oncology Information System
Pending LLM rewrite. Source: FDA_DEVICE Z-2406-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
The recalled product
- Product
- MOSAIQ Oncology Information System
- Manufacturer
- Elekta, Inc.
- Category
- Medical Device — Devices
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
Distributed nationwide across the United States.
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