GE Imactis CT navigation may show needle trajectory that differs from actual
GE Medical Systems is recalling the Imactis CT-Navigation System because of a potential discordance between the simulated needle trajectory and tip position and the actual trajectory and tip position.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the displayed needle path may not match where the needle actually is during a guided procedure, and no injuries are stated.
Plain-English summary
GE Medical Systems, LLC is recalling the Imactis CT-Navigation System, a stereotaxic accessory for computed tomography systems, model numbers E85101LA and E85101LP. About 125 units were distributed worldwide, covering the United States nationwide. The FDA has classified this recall as Class II.
There is a potential issue that can lead to discordance between the simulated needle trajectory and tip position and the actual needle trajectory and tip position.
Affected systems are listed by identifier in the FDA enforcement record, under HIBC +B681J02000.
Facilities can identify affected systems by the model numbers above, and may contact GE Medical Systems, LLC for further information.
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
- Affected units
- 125
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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