[pending] Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Num
Pending LLM rewrite. Source: FDA_DEVICE Z-1590-2026.
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
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
The recalled product
- Product
- Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
- Manufacturer
- GE Medical Systems, LLC
- 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)
- HIBC: +B681J02000
Distribution
Distributed nationwide across the United States.
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