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 70197039709975887593759875997600760476057596M
- GEMINI TF PET/CT 64
882471 702770447146715371787182718875787579758575877589759275947595760276037606
- GEMINI TF Big Bore
882476 9019922792329233
- GEMINI TF PET/CT16
- 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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