Recall Z-0343-2012 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional i
| Date | Dec 1, 2011 (initiated Apr 25, 2011) |
| Status | Terminated |
| Reason | In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, 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 | Philips Healthcare sent a "CPE CUSTOMER LETTER" dated October 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Additionally, device operation information is provided to customers. A Philips Field Service Engineer will be visiting each customer site to install the necessary software upgrades. Contact the Customer Care Solutions Center at 1-800-722-9377 for questions concerning this notice. |
| Quantity | 9 units |
| Distribution | Nationwide Distribution including the states of CO, LA, MD, MI, MN, PA, TX, VA, VT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081135 | GEMINI CONDOR Philips Medical Systems (Cleveland), Inc., Apr 29, 2008 |