FDA-Device2015-10-14Class II

Celesteion PCA-9000A/2 PET/CT System

Toshiba American Medical Systems Inc
Hazard

It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.

Sold states
US Distribution to the state of Nevada.
Affected count
1
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
Celesteion PCA-9000A/2 PET/CT System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0005-2016

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