Recall Z-0361-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment
| Date | Dec 2, 2011 (initiated Sep 6, 2011) |
| Status | Terminated |
| Reason | Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems. |
| Root cause | Software design |
| Action | Philips Healthcare released a 'Field Change Order' (FCO #72800542) on September 15, 2011. Philips sent an URGENT - Medical Device Correction letter dated October 10, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to the situation. The letter was mailed by Philips to their customers on October 27, 2011. The letter provided information telling the customer how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Re |
| Quantity | 2 units |
| Distribution | Worldwide Distribution - USA including Ohio and the countries of Australia, China, Belgium, Israel, and Sweden |
| 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 |