Reported Jul 16, 2014 · Terminated

GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for…

Philips Medical Systems (Cleveland) 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: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131

Is this the product you have?

  • GEMINI TF PET/CT16882470
  • GEMINI TF PET/CT 64882471
  • GEMINI TF Big Bore882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems
Lot codes and dates
  • GEMINI TF PET/CT16
    • 882470 7019
    • 7039
    • 7099
    • 7588
    • 7593
    • 7598
    • 7599
    • 7600
    • 7604
    • 7605
    • 7596M
  • GEMINI TF PET/CT 64
    • 882471 7027
    • 7044
    • 7146
    • 7153
    • 7178
    • 7182
    • 7188
    • 7578
    • 7579
    • 7585
    • 7587
    • 7589
    • 7592
    • 7594
    • 7595
    • 7602
    • 7603
    • 7606
  • GEMINI TF Big Bore
    • 882476 9019
    • 9227
    • 9232
    • 9233
Amount recalled
33

Where it was sold

Why it was recalled

When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occurs randomly.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 16, 2015 · Data as of Sep 19, 6:51 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.