FDA-Device2021-10-27Class II
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Canon Medical System, USA, INC.
Hazard
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
Sold states
US Nationwide distribution in the states of NV, AR MN.
Affected count
3 units
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0142-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief