FDA recall Z-2316-2021

Product

728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

Reason for recall

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Distribution

US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

Key facts

Status

Terminated

Initiation date

2021-06-08

Report date

2021-08-25

Termination date

2023-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2316-2021