Recall Z-0019-2014 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
| Date | Oct 17, 2013 (initiated Jul 22, 2013) |
| Status | Terminated |
| Reason | A pinch point at the end of the table top can cause injury. |
| Root cause | Use error |
| Action | Field Safety Notice (FSN 72800601_72800603, will be sent to all US consignees via certified mail. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. |
| Quantity | 326 |
| Distribution | Worldwide Distribution-USA including the states of AL, AR, CA, FL, GA, IL, IN, KY, MS, NC, NJ, NV, NY, OH, PA, and VA; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, China, Ghana, Greece, India, Indonesia, Ireland, Italy, Jordan, Latvia, Lebano |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083498 | PHILIPS MODEL MX 16 SLICE CT SYSTEM Philips Medical Systems (Cleveland), Inc., Dec 17, 2008 |