Recall Z-1353-06 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems North America Co. Phillips
Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option
| Date | Aug 3, 2006 (initiated Jul 1, 2006) |
| Status | Terminated |
| Reason | Potential for measurements, lines, texts, etc to be stored incorrectly. |
| Root cause | Other |
| Action | On 7/1/06 the firm issued a letter to consignees stating the problem and how to prevent the problem. The firm reports a software update will be issued no later than September 2006 to correct the problem. |
| Quantity | 157 devices |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033088 | SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 Sectra AB, Oct 29, 2003 |