Recall Z-0945-2013 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices 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 include signal analysis and display eq
| Date | Mar 13, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| Reason | Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake. |
| Root cause | Component design/selection |
| Action | Philips Healthcare sent a "Urgent Medical Device Correction" letter dated December 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed Philips received reports from the field stating that the screws holding the vertical brake together failed. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. If you need any further information please contact your local Philips representative or local Philips Healthcare office. For North America and |
| Quantity | 4797 Units |
| Distribution | Worldwide Distribution - Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010817 | MX8000 V5.0 CT SYSTEM Philips Medical Systems (Cleveland), Inc., Jun 15, 2001 |
| K012009 | MX8000 IDT CT SYSTEM Marconi Medical Systems, Inc., Sep 13, 2001 |
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |