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
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