# FDA recall Z-2651-2026

> **PHILIPS MEDICAL SYSTEMS** · Class II · device recall initiated 2026-06-11.

## Product

IQon Spectral CT  IQon Spectral CT Upgrades

## Reason for recall

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

## Distribution

US Nationwide Distribution including Puerto Rico

## Key facts

- **Recall number:** Z-2651-2026
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-11
- **Report date:** 2026-08-05

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2651-2026

## Citation

> AI Analytics. FDA recall Z-2651-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2651-2026. Source: US FDA. Licensed CC0.

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