Auris Health Inc. is recalling 330 units of the Monarch Platform (Software Version 2.2.4) due to a software defect. This issue can cause the virtual bronchoscope view to display a flipped image during medical procedures. The recall affects models MON-000005-01, MON-000005-01R, and MON-000006. While no injuries have been reported in this notice, the incorrect visual orientation could lead to navigation errors during surgery.
A flipped image in the virtual bronchoscope view can cause medical professionals to misinterpret the device's orientation inside the patient. This may lead to incorrect instrument placement or navigation errors, potentially resulting in tissue damage or procedural delays.
Manufacturer Notification and Correction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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