FDA (Devices) recall action 93320
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
AURIS HEALTH INC is recalling approximately 110 units of the Monarch Platform bronchoscopy surgical device due to a software defect that can flip the displayed image during procedures. No injuries have been reported.
Auris Health is recalling 110 units of the Monarch Platform bronchoscope due to a software defect that may flip the image display. This inverted view could impact visualization during airway procedures.
AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.