Medical device recalls Moderate risk

Toshiba American Medical Systems Inc recalls Celesteion PCA-9000A/2 PET/CT System

Recall date
May 8, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0005-2016
FDA classification
Class II
Brand / firm
Toshiba American Medical Systems Inc
Sold / distributed
US Distribution to the state of Nevada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Celesteion PCA-9000A/2 PET/CT System

Get recall alerts

Free email alert whenever Toshiba American Medical Systems Inc has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Toshiba American Medical Systems Inc