FDA recall Z-2451-2026

Product

Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Reason for recall

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

Distribution

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Libya, Malaysia, Mexico, Morocco, Nepal, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Key facts

Status

Ongoing

Initiation date

2026-05-19

Report date

2026-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boxborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2451-2026