Recall Z-0767-2013 ยท KPR System, X-Ray, Stationary
Philips Healthcare Inc.
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
| Date | Feb 1, 2013 (initiated Jan 16, 2013) |
| Status | Terminated |
| Reason | The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. |
| Root cause | Software design (manufacturing process) |
| Action | Phillips issued an Urgent Field Safety Notice to all customers on January 14, 2013, to notify users that the Phillips EasyDiagnost Eleva systems, release 3.0 has a mirror icon that could be misinterpereted and could potentially lead to misdiagnosis. Philips will upgrade the system to version 3.1 which involves software and hardware upgrades of the system. This software provides a replacement icon that reduces the risk of the potential misinterpretation of the original mirror icon. Additionally, Philips will provide updated Instructions for Use (IFU) for the Eleva workspot and the EasyDiagnos |
| Quantity | 14 units |
| Distribution | US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO. |
| 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 |