Recall Z-2451-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may i
| Date | Sep 25, 2012 (initiated Aug 21, 2012) |
| Status | Terminated |
| Reason | A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. |
| Root cause | Nonconforming Material/Component |
| Action | Philips Healthcare sent an Urgent Medical Device Correction letter dated August 22, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that no action needed to be taken at that time b the customer or user. A Philips Field Service Engineer would schule a time to inspect and repair all the affected systems within approximately 6 months. For further information customers were instructed to contact their local Philips representative or contact the Philips Healthcare Customer Care Solution Center at |
| Quantity | 112 Units |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Mexico, Saudi Arabia, South Korea, Spain, Thailand, Turkey & Un |
| FDA record | Open on fda.gov |