FDA recall Z-2101-2025

Medtronic Navigation, Inc.-Boxborough · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-05-27
Report date
2025-07-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boxborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2101-2025