Monarch Platform Bronchoscope Software Issue Causes Flipped Display
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.
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: This is a Class II recall for a medical device where a software defect poses a potential risk of harm during clinical procedures. No illnesses or injuries are reported, and the hazard is described as 'potential,' making this a risk-of-harm scenario without actual harm reported, placing it at the 'High' severity level per the rubric.
Plain-English summary
The Monarch Platform (model REF MON-000005-01R) is a medical device manufactured by Auris Health for bronchoscopic visualization. Auris Health is recalling 110 units due to a potential software defect affecting the image display.
The software issue in version 2.2.4 may cause the virtual bronchoscope image to appear flipped or inverted. An inverted image could impact the physician's ability to correctly visualize and navigate the airway during examination and treatment procedures.
Affected units have been distributed across 32 U.S. states: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Washington D.C., Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and West Virginia.
Healthcare facilities with affected units should discontinue use and contact Auris Health for information regarding software updates or device replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
- Manufacturer
- AURIS HEALTH INC
- Hazard
- image-flip
- software-defect
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)
- Software version 2.2.4
Distribution
Distributed in 34 states:
- AK
- AL
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- IL
- IN
- KY
- MA
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NY
- OH
- OR
- PA
- SC
- SD
- TN
- TX
- WI
- WV
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