Recall Z-2915-2011 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. T
| Date | Aug 1, 2011 (initiated Aug 5, 2009) |
| Status | Terminated |
| Reason | Two non-safety related defects have been found on the Philips GEMINI TF Big Bore running version 3.6; if these defects were to recur, it could impact the performance or reliability of the system. Philips is issuing a software update to all Philips GEMINI TF Big Bore customers to correct these defects. |
| Root cause | Software design (manufacturing process) |
| Action | Philips Medical Systems (Cleveland) Inc. sent an "GEMINI TF BIG BORE CPE CUSTOMER LETTER" dated October 20, 2011 to all affected customers. The letter describes the product, problem, and updates that are available to the customers. The letter provides additional information about acquisition workflows for SUV Calibrations and Validations. For support concerning this upgrade, contact the Customer Care Solutions Center at 1-800-722-9377. |
| Quantity | 23 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of CO, LA, MD, MI, MO, MN, PA, TX, VA, VT and WI and the countries of Belgium, Germany, Italy, Saudi Arabia and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081135 | GEMINI CONDOR Philips Medical Systems (Cleveland), Inc., Apr 29, 2008 |