Recall Z-0409-2016 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
| Date | Dec 10, 2015 (initiated Mar 3, 2011) |
| Status | Terminated |
| Reason | Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis. |
| Root cause | Software design |
| Action | On March 3, 2011, the firm sent Field Service Notices to their customers. |
| Quantity | 1,765 units |
| Distribution | Worldwide Distribution. US nationwide, including Puerto Rico, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Equatorial Guinea, Finland, France, Germany, Greece, Hungary, Icel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |