MIRA SURGICAL SYSTEM, Table mounted miniaturized… recallZ-1905-2025 · Virtual Incision Corporation · initiated Apr 23, 2025

Completed

Is my device affected?

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.
If yours is listed, follow the instructions from Virtual Incision Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
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

The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.

FDA root cause category: Software design

What the company is doing

A "MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated 4/22/25 was sent to customers. Actions to be taken by the Customer/User: Do not use the device and transition scheduled procedures to another minimally invasive surgical technique i.e. laparoscopic or other robotic assisted device. Remove the device from service using your internal institutional procedures (e.g. Lock-Out, Tag-Out) for device maintenance until Virtual Incision technicians service the devices on hand. There is no anticipated impact to the conduct of the clinical study under the IDE. Please complete the attached Acknowledgement and Receipt form and return to Virtual Incision to indicate you received this letter. Customer Service, Clinical Support Staff, [email protected],913-608-3214. Quality Assurance, Sr Director of Quality and Manufacturing Engineering, [email protected], 308-529-1987. Regulatory Affair, VP of Clinical and Regulatory Affairs, [email protected], 352-275-726. Type of Action by the Company: Virtual Incision will be working with your site representatives to schedule on-site servicing of the device with updated software for the Surgeon Control Console within 30 days from receipt of this letter. Immediate corrections have been implemented through the analysis of the system data. Results indicate that implemented software updates have resolved the issue that could contribute to this deficiency in the future. If you have any question, call 513-500-4459 or email: [email protected].

Recall details

Recall number: Z-1905-2025
Status: Completed
Initiated by the company: Apr 23, 2025
Posted by the FDA: Jun 4, 2025
Recalling firm: Virtual Incision Corporation
Quantity: 3 units
Product code: SAB
Distribution: US Distribution to States: CA, FL, NE

Product description

MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3

Code information (models, lots, serial numbers)

UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

MIRA 180-020000-000
Virtual Incision Corporation · Table Mounted Miniaturized Electromechanical Surgical System
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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