Recall Z-2346-2016 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
| Date | Apr 20, 2016 |
| Status | Terminated |
| Reason | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patients images before pasting, a previous patients images may be present in the clipboard and be copied onto the film of the current patient. 2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker |
| Root cause | Software design |
| Action | On April 20, 2016 the firm sent Field Safety Notices to their customers. Philips will release a Field Change Order to upgrade the software free of charge. A Philips Field Engineer will contact their customers to schedule this correction. |
| Quantity | 899 units |
| Distribution | Products were sold in the following states: AL, AR, CA, FL, GA, IL, IN, MS, NC, ND, NJ, NV, NY, OH, PA, SC, TN & VA. Products were also shipped to the following countries: Albania, ALGERIA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Cape Verde, Chile, China, Colo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091195 | PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 Philips Medical Systems (Cleveland), Inc., May 27, 2009 |