Recall Z-0806-2007 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare
GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3.
| Date | May 15, 2007 (initiated Dec 21, 2006) |
| Status | Terminated |
| Reason | Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis. |
| Root cause | Other |
| Action | A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction. |
| Quantity | 4 |
| Distribution | Worldwide Distribution: USA in the following states and locations: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, Guam and Puerto Rico. Foreign c |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050559 | GE DISCOVERY VCT SYSTEM GE Medical Systems, Mar 17, 2005 |