FDA recall Z-2650-2026

Product

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 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

Status

Ongoing

Initiation date

2026-06-11

Report date

2026-08-05

Voluntary/Mandated

FDA Mandated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2650-2026