Endoscopy and Bronchoscopy Systems Power Cord Defect Risk
Monarch Platform endoscopy and bronchoscopy systems may have defective power cords causing electrical shorts and shock risk if exposed wires are touched, potentially leading to system shutdown.
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 an FDA Class II recall of medical devices with a documented electrical hazard (power cord strain relief defect causing potential electrical short and shock). No injuries or illnesses have been reported. The hazard presents a risk of harm to users and potential treatment disruption, but without reported incidents, this corresponds to High severity per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Monarch Platform endoscopy and bronchoscopy systems (manufactured by AURIS HEALTH INC) are subject to recall due to a strain relief defect in cart and tower power cords. Affected models include MON-000005-01, MON-000005-01R, MON-000006, and MON-000006-RFB, with 176 units distributed worldwide, including across all US states and Canada.
The defective power cords may cause an electrical short, which could lead to system shutdown during procedures. If operating room staff or other users touch exposed wires or conductive fluids in contact with the wires, there is a risk of electrical shock.
System shutdown during an endoscopic or bronchoscopic procedure could result in case conversion or prolonged procedure time, potentially affecting patient care. Facilities with affected systems should take appropriate action based on manufacturer guidance.
The recalled product
- Product
- Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
- Manufacturer
- AURIS HEALTH INC
- Hazard
- electrical-short
- electrical-shock
- system-shutdown
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 (20)
- Cart Power Cord 20' 14AWG BLK
- PN 304-003613-00. Tower Power Cord 20' 14AWG BLK
- 13
- 110014
- 110016
- 110040
- 110038
- 110027
- 110035
- 110022
- 110034
- 1806P2
- 120170
- 110045
- 110039
- 110049
- 110047
- 110052
- 110030
- 110032
Distribution
Distributed nationwide across the United States.
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