GE Medical Systems recalled 125 Imactis CT-Navigation System stereotaxic accessories distributed worldwide to healthcare facilities. The recall cites a potential mismatch between the simulated needle trajectory and the actual trajectory. Healthcare providers should stop using the devices immediately and follow the manufacturer's recall instructions.
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, LLC or your healthcare provider for instructions. Notification method: Letter
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The Imactis CT-Navigation System is a stereotaxic accessory used to guide needle placement in CT-guided procedures.
A mismatch between the planned needle path and the actual needle path could lead to incorrect guidance during procedures.
This recall is not stated as part of a broader industry pattern.
Healthcare facilities must halt use to prevent potential procedural inaccuracies and seek manufacturer guidance.
Check device label for model numbers, packaging for IMB codes, and the FDA recall page for official notices.
Recall processing and replacement/refund instructions will be provided by GE Medical Systems; expect communications from the manufacturer.
Retain the recall letter, take photos of the device label, record all communications with GE Medical Systems, and log the model/IMB codes of affected units
Model numbers: E85101LA and E85101LP. Distribution: Worldwide distribution, with US nationwide. Sold to: healthcare facilities. Price: Unknown.
No injuries or incidents have been reported.
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