Recall Z-0597-2009 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners. The device is a vertical drive brake that controls the vertical position of a patient support system or couch. The patient support system is intended to be used to place the patient in the correct horizontal and vertical position in order to be scanned. The couch is a
| Date | Jan 16, 2009 (initiated Sep 23, 2008) |
| Status | Terminated |
| Reason | The product is being recalled because the patient support may travel downwards without being commanded to move. |
| Root cause | Process control |
| Action | A On 11/15/2007 & 6/6/2008 the firm sent Urgent Device Notification letters to their customers. They notified their customers that a Field Service Engineer will inspect and repair the brake system. |
| Quantity | 559 |
| Distribution | Worldwide Distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and countries of Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Can |
| 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 |