Z-1905-2025Class II

MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number...

Name: Z-1905-2025 MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number...
Creator: Virtual Incision Corporation
Published: 2025-04-23
License: https://open.fda.gov/license/

Virtual Incision Corporation / initiated 2025-04-23 / Completed / root cause: software

FDA source

VIRTUAL INCISION CORPORATION began a recall of MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3 on 2025-04-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-1905-2025
Classification: Class II
Status: Completed
Initiated: 2025-04-23
Posted: 2025-06-04
Recalling firm: Virtual Incision Corporation
Product: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Product code: SAB Table Mounted Miniaturized Electromechanical Surgical System
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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].
Quantity in commerce: 3 units
Distribution: US Distribution to States: CA, FL, NE
Product codes and lots: UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1905-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1905-2025	Class II	Completed	Voluntary: Firm initiated	2025-06-11	2025-06-04

Product code SAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)