The Recall Desk
HighFDA (Devices)·Z-2101-2025·Announced 2025-07-16

O-arm O2 Imaging System: Damaged Mechanical Support Component Recall

Medtronic is recalling 3 units of the O-arm O2 Imaging System (mobile X-ray equipment) in IN, MN, and MS due to potential damage to a mechanical component supporting the gantry during manufacturing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of medical imaging equipment due to potential damage to a mechanical support component. No injuries have been reported, but the structural nature of the defect constitutes a risk-of-harm scenario.

Plain-English summary

The O-arm O2 Imaging System is a mobile X-ray system manufactured by Medtronic Navigation, Inc. The recall involves three units with serial numbers C4014, C4017, and C4019.

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

The affected units were distributed to facilities in Indiana, Minnesota, and Mississippi. This is a Class II medical device recall issued by the FDA.

The recalled product

Product
O-arm O2 Imaging System. Mobile X-Ray System.
Manufacturer
Medtronic Navigation, Inc.-Boxborough
Category
Medical Device — Imaging Equipment
Hazard
  • structural-defect
  • mechanical-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • CFN: BI70002000
  • UDI: 00763000709631
  • Serial No. C4014
  • C4017
  • C4019.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category