Recall Z-0197-2016 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
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.
| Date | Nov 2, 2015 (initiated May 1, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Philips field service personnel will conduct customer visits in order to inspect systems. For further questions please call (440) 483-7600. |
| Quantity | 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, Denma |
| FDA record | Open on fda.gov |