GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Reported: November 11, 2015 Initiated: May 1, 2008 #Z-0197-2016
Product Description
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Reason for Recall
The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 264 units
- Distribution
- Worldwide Distribution - US Distribution to the states of : AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Canada, Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Luxembourg, Mexico, Netherlands, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and UK.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 264 units.
Why was this product recalled? ▼
The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Moderate. Recall number: Z-0197-2016.
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