Recall Z-0675-2013 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scan
| Date | Jan 16, 2013 (initiated Sep 11, 2012) |
| Status | Terminated |
| Reason | Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu. |
| Root cause | Software design |
| Action | Philips Healthcare sent a "CUSTOMER INFORMATION -URGENT-MEDICAL DEVICE CORRECTION" letter dated September 13, 2012. The letter identified the product, problem, and actions to be taken by the customers. Philips Service Engineers will contact customers for implementation of the software update. Contact your local Philips representative or local Philips office for further information concerning this notice. |
| Quantity | 108 units |
| Distribution | Worldwide Distribution-USA including the states of AZ, CA, CO, IL, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA and WI and the countries of Austria, Canada, China, France, India, Ireland, Italy, Japan, Netherlands, Norway, Spain, Switzerland, Thailand and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961464 | SELECT/SP Elscint, Inc., Jul 3, 1996 |