Monarch™ Software Tower v2.2.5 Version 2.2.5

• FDA 510(k) K211493 decided 9 Jul 2021 Active
• FDA GUDID UDI-DI 10810068810766 listed 16 Feb 2024 Listed

• • Ongoing Z-1383-2026 FDA Class II ·initiated 21 Jan 2026

  Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.

• • Ongoing Z-0051-2025 FDA Class II ·initiated 2 Aug 2024

  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.

1. 9 Jul 2021 Cleared FDA 510(k) K211493
2. 16 Feb 2024 Listed FDA GUDID 10810068810766
3. 2 Aug 2024 Recall initiated FDA recalls Z-0051-2025
4. 21 Jan 2026 Recall initiated FDA recalls Z-1383-2026

Trade name

Monarch™ Software Tower v2.2.5

Generic name

Robotic surgical system application software

Model / reference

Version 2.2.5

Primary DI / UDI-DI

10810068810766

510(k) Number

K211493 ↗

FDA product code

EOQ, JAK

GMDN term

Robotic surgical system application software

Device class

Class II

Regulation number

874.4680, 892.1750

GUDID distribution status

In Commercial Distribution

Category: Robotic surgical system application software

Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).

• GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 by Gimmi GmbH
• KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE by Karl Storz Endoscopy-America, Inc.
• DUAL-LUMEN CATHETER by Bistech, Inc.
• Ion Endoluminal System by Intuitive Surgical, Inc.
• Karl Storz Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) by Karl Storz SE & CO. KG
• B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM by Vision-Sciences, Inc.
• 490110 by Intuitive Surgical, Inc.
• RIGID FIBEROPTIC ENDOSCOPES by Kelleher Corp.
• 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE by Karl Storz Endoscopy-America, Inc.
• Single-Use Video Bronchoscope SVB11001 by Micro-Tech (Nanjing) Co., Ltd.

• MONARCH™ Navigation Sensors MON-000705 Open recall

  Class II

  FDA 510(k) K193534 Active Cleared 15 Apr 2020 GUDID on market

• MONARCH™ Controller MON-000706 Open recall

  Class II

  FDA 510(k) K193534 Active Cleared 15 Apr 2020 GUDID on market

• MONARCH™ Advanced Imaging Accessory Kit MON-000709 Open recall

  Class II

  FDA 510(k) K211493 Active Cleared 9 Jul 2021 GUDID on market

• MONARCH™Platform, Urology MON-000007 Open recall

  Class II

  FDA 510(k) K213334 Active Cleared 29 Apr 2022 GUDID on market

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