# FDA recall Z-2451-2026

> **Medtronic Navigation, Inc.-Boxborough** · Class II · device recall initiated 2026-05-19.

## 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

- **Recall number:** Z-2451-2026
- **Recalling firm:** Medtronic Navigation, Inc.-Boxborough
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-19
- **Report date:** 2026-06-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boxborough, MA, United States

## Primary source

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

## Citation

> MORVS. FDA recall Z-2451-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2451-2026. Source: US FDA. Licensed CC0.

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