Medtronic Navigation, Inc.-Boxborough: Medical Device Recall in 2025 - (Recall #: Z-2101-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

O-arm O2 Imaging System. Mobile X-Ray System.

Product Classification:

Class II

Date Initiated: May 27, 2025

Date Posted: July 16, 2025

Recall Number: Z-2101-2025

Event ID: 97045

Reason for Recall:

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

Status: Ongoing

Product Quantity: 3 units

Code Information:

CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.

Distribution Pattern:

US Nationwide distribution in the states of IN, MN, MS.

Voluntary or Mandated:

Voluntary: Firm initiated