Monarch Platform recall
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Why was Monarch Platform 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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/+B634MON0000070/120059, 120133, 210002; MON-000007-RFB/10810068810889/210001.
- Product
- Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
- Recalling firm
- AURIS HEALTH INC
- Quantity
- 4
- Distribution
- Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.
- Recall date
- October 16, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)