Recall Z-0801-2014 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
| Date | Jan 21, 2014 (initiated Dec 4, 2013) |
| Status | Terminated |
| Reason | Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed. |
| Root cause | Software design |
| Action | On 12/4/2013 the firm sent Urgent Medical Device Corrections letters to their customers. |
| Quantity | 32 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AK, MD, NH, NV, OH, and OR, and the countries of Australia, China, France, India, Indonesia, Italy, Korea, Mexico, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Thailand & United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |