Reported Oct 16, 2024 · Ongoing
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Auris Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AURIS HEALTH INC · 150 Shoreline Dr · Redwood City, CA · 94065-1400
Is this the product you have?
- Monarch Platform (Urology)
- REF
MON-000007MON-000007-RFB
- Lot codes and dates
- Cart Power Cord 20' 14AWG BLK, PN 304-003613-00. Tower Power Cord 20' 14AWG BLK, PN 304-003607-00
- REF/UDI-DI/Serial Numbers
MON-000007/+B634MON0000070/120059120133210002MON-000007-RFB/10810068810889/210001
- Amount recalled
- 4
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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