Recall Z-1464-2014 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
| Date | Apr 16, 2014 (initiated Mar 6, 2014) |
| Status | Terminated |
| Reason | A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete. |
| Root cause | Software in the Use Environment |
| Action | .The firm, Phillips, sent an " URGENT Medical Device Correction" letter dated 2013 March 06, to its costumers . The letter disc ribes the product, problem and actions to be taken. The costumers were instructed to Verify that all planned image reconstructions are completed, and Perform off-line reconstructions if expected images are missing. The firm will release A Field Change Order (FCO) to correct the issue with software version release 3.5.7.and A Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any further information or sup |
| Quantity | 116 units |
| Distribution | Worldwide Distribution:US ( Nationwide) Including stages of MI, OR, PA, TX & WV; and Countries of: Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, France, Germany, India, Indonesia, Ireland, Japan, Nicaragua, Oman, Palestine, Russia, South Korea, Spain, Switzerland, Thailand, Turkey & Unit |
| 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 |