Monarch Platform Bronchoscopy Device Recalled for Software Image Inversion
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.
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: This is an FDA Class II medical device recall involving a concrete software defect that can impair surgical visualization during bronchoscopy. It qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity rubric criterion.
Plain-English summary
The Monarch Platform (REF MON-000006, 100-240V, software version 2.2.4) is a surgical platform used for bronchoscopic procedures. It is manufactured by AURIS HEALTH INC.
A software defect in version 2.2.4 can cause the virtual bronchoscope image to display in an inverted or flipped orientation. An incorrectly oriented image during a bronchoscopic procedure could lead to procedural errors or complications.
The device has been distributed to healthcare facilities across 32 U.S. states including Alaska, Alabama, Arizona, California, Colorado, Connecticut, 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. No illnesses or injuries have been reported in association with this defect.
Healthcare providers using the Monarch Platform should contact AURIS HEALTH INC for information regarding software correction or device remediation procedures.
The recalled product
- Product
- Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
- Manufacturer
- AURIS HEALTH INC
- Category
- Medical Device — Bronchoscopy
- Affected units
- 110
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
Part of a larger recall action
This product is one of 3 recalled by AURIS HEALTH INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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