Recall Z-0431-2014 ยท KPR System, X-Ray, Stationary
Philips Medical Systems, Inc.
Easy Diagnost Eleva Universal Fluoroscopic applications
| Date | Dec 2, 2013 (initiated Oct 30, 2013) |
| Status | Terminated |
| Reason | The delivered application software was an outdated version to the model of equipment. |
| Root cause | Software design |
| Action | Philips Medical Systems sent an Urgent - Field Safety Notice dated October 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of its contents. Customers with questions were |
| Quantity | 19 devices |
| Distribution | Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031535 | PHILIPS EASYDIAGNOST ELEVA Philips Medical Systems North America Co., Jun 17, 2003 |