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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 3, 2015 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.