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Monarch Platform (Endoscopy), REF: MON-000005-01… recallZ-0051-2025 · Auris Health Inc · initiated Aug 2, 2024

Class II Open, Classified All recalls posted in October 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Auris Health Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

On 8/2/24, field safety notices were emailed to customers informing them of the following: 1) If the flow of electricity stops, the system may switch to battery backup power to allow for safe system shutdown. 2) Prior to use, carefully inspect the cords for any signs of excessive wear or damage while not plugged into an electrical outlet. 3) Firm is sourcing new replacement power cords to increase their robustness. New power cords will be provided as replacements once they are available. A member of MONARCH support will contact you to coordinate the replacement. 4) Forward this notice to any personnel in your facility who need to be informed. If any affected products have been forwarded to another facility, contact that facility and provide a copy of this notice to the relevant personnel. 5) Complete are return the acknowledgement form via email to [email protected] 6) If you feel that your power cord is damaged or defective or have questions , please contact MONARCH Support at 1-800-434-0032 or [email protected] to obtain a replacement that has been screened for this defect.

Recall details

Recall number
Z-0051-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 2, 2024
Posted by the FDA
Oct 10, 2024
Recalling firm
Auris Health Inc
Quantity
176
Product code
EOQ
FDA submissions
K211493
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.

Product description

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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-000005-01/+B634MON000005010/110024, 13, 110014, 110016, 110040, 110038, 110027, 110035, 110022, 110034, 1806P2, 120170, 110045, 110039, 110049, 110047, 110052, 110030, 110032, 110021, 110043, 110050, 110029, 110033, 110046, 110048, 110018, 110015, 110051, 1806P1, 110012, 14, 110041, 110036; MON-000005-01R/+B634MON00000501R0/110020, 110017, 110031, 110028, 120042, 110013. MON-000006/+B634MON0000060/120088, 120057, 120046, 120058, 120121, 120152, 120015, 120160, 120068, 120167, 120025, 120030, 120044, 120093, 120040, 120063, 120092, 120173, 120036, 120064, 120122, 120056, 120128, 120017, 120089, 120075, 120031, 120169, 120113, 120168, 120055, 120148, 120014, 120060, 120124, 120164, 120123, 120007, 120006, 120004, 120120, 120126, 120082, 120047, 120051, 120020, 120103, 120153, 120108, 120037, 120074, 120005, 120130, 120095, 120096, 120009, 120111, 120022, 120054, 120163, 120027, 120090, 120141, 120072, 120155, 120101, 120143, 120125, 120052, 120100, 120050, 120098, 120045, 120131, 120013, 120105, 120165, 120136, 120029, 120041, 120139, 120137, 120053, 120028, 120034, 120085, 120019, 120049, 120209, 120144, 120161, 120001, 120145, 120127, 120011, 120070, 120076, 120134, 120117, 120077, 120149, 120102, 120002, 120010, 120003, 120023, 120146, 120043, 120071, 120107, 120065, 120116, 120150, 120066, 120166, 120033, 120079, 120008, 120132, 120086, 120032, 120073, 120016, 120080, 120078, 120012, 120084, 120083, 120038, 120067, 120021; MON-000006-RFB/+B634MON0000060/120081, 120026, 120091, 120106, 120104.

Other devices under the same FDA submission

1 device cleared under K211493 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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