Recall Z-2245-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer recons
| Date | Aug 22, 2012 (initiated Aug 3, 2012) |
| Status | Terminated |
| Reason | The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch. |
| Root cause | Device Design |
| Action | Philips Medical Systems (Cleveland), Inc. sent an Urgent - Medical Device Correction letter dated August 1, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taked. The letter contained important information for the continued safe and proper use of your equipment. The letter stated that, a Field Service Engineer will visit each affected site to install the hardware upgrade. For further information or support concerning this issue contact your local Philips representative or local Philips Health office. For North America and Canada conta |
| Quantity | 126 units |
| Distribution | Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, DC, FL, GA, KY, MD, MI, MN, MS, ND, NM, NY, OH, OK, SC, TN, TX, VT, WA, and WI and the countries of: Austria, China, Denmark, France, Germany, Iceland, Japan, Netherlands, South Africa, Sweden, Switzerland, United Kingd |
| FDA record | Open on fda.gov |