Recall Z-3201-2011 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206. The recalled GEMINI TF Big Bore system units equipped with software version: 3.6.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations tha
| Date | Sep 13, 2011 (initiated May 31, 2011) |
| Status | Terminated |
| Reason | The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the these PET/CT system units. |
| Root cause | Software design |
| Action | The firm , Philips Healthcare, issued a 'Customer Information Letter' dated August 9, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were not required to perform any action. A Philips' Field Service Engineer will visit each customer site and install the necessary software upgrade and Philips will track the progress of the software corrections as they take place. For customers in North America, if you need any further information or support concerning this update, please contact our Customer Care Solutions Center at 1-800-722-9377. Sele |
| Quantity | 6 units |
| Distribution | Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081135 | GEMINI CONDOR Philips Medical Systems (Cleveland), Inc., Apr 29, 2008 |