Recall Z-0805-2012 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model #882471 Philips Medical Systems, Highland Heights, OH The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
| Date | Jan 18, 2012 (initiated Dec 2, 2011) |
| Status | Terminated |
| Reason | Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed. |
| Root cause | Software design |
| Action | Philips Medical System sent a Urgent Medical Device Correction letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following are recommended actions: 1. Please ask your local Philips Service Engineer to ensure that the Auto Delete function is configured to run automatically. 2. Please share this information with all Philips GEMINI TF system operators at your site. 3. Retain this document with your system's instructions for Use Manual. For further information or support concerning thi |
| Quantity | 197 units |
| Distribution | Worldwide Distribution -- USA (nationwide) including the states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NY, OH, OR, PA, PR, TN, TX, WA and WV. and the countries of: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Denmark, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc., Oct 7, 2005 |