Reported Oct 14, 2015 · Terminated
Celesteion PCA-9000A/2 PET/CT System
Toshiba American Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toshiba American Medical Systems Inc · PO Box 2068 · Tustin, CA · 92780-7047
Is this the product you have?
- Celesteion PCA-9000A/2 PET/CT System
- Lot codes and dates
- ModelTSX-301 CI6A with system software V7.0 SPOO04J
- Amount recalled
- 1
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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