Recall Z-2053-2008 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems North America Co. Phillips
EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard and mouse, and software. The viewing, analysis, processing and printing functions are sent to the EasyVision by means of PMSNet (Philips M
| Date | Sep 16, 2008 (initiated Mar 10, 2008) |
| Status | Terminated |
| Reason | Inaccurate measurements when exporting radiography images to Picture Archiving and Communication System (PACS ). |
| Root cause | Device Design |
| Action | On 03/14/08 the firmed mailed certified letters to the customers of the device. The letter advises of the problem and stated that images exported from the Easy Vision RAD workstation should not be used for measurements. The letter also states that the firm will be performing upgrades of the devices. If you have questions, contact Sarah Baxter at 425-487-7665 or the Philips Call Center at 800-722-9377, #5, #2. |
| Quantity | 401 units |
| Distribution | Products were distributed nationwide to 159 hospitals, 3 VA's and 12 Department of Defense accounts. |
| FDA record | Open on fda.gov |