Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
FDA Recall Z-1464-2014 · Posted 2014-04-16
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2014-03-06
Date Terminated2014-11-05
Product Quantity116 units
Reason for Recall
A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
Firm 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 support concerning this issue, please
contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).
Root Cause
Software in the Use Environment
Distribution Pattern
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 & United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.