Recall Z-0979-2014 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
| Date | Feb 12, 2014 (initiated Dec 5, 2013) |
| Status | Terminated |
| Reason | The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study. |
| Root cause | Software design |
| Action | ON 12/5/2013 the firm sent Medical Device Correction Letters to their customers. |
| Quantity | 47 Units |
| Distribution | Product was shipped to the following states: AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT & WI. Product was also shipped to the following countries: Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia & Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081135 | GEMINI CONDOR Philips Medical Systems (Cleveland), Inc., Apr 29, 2008 |