Recall Z-1882-2011 ยท LLC
Philips Medical Systems
iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101, and 4.1.110 ; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA ViewForum Applications: iSite ViewForum Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "o
| Date | Apr 4, 2011 (initiated Feb 23, 2011) |
| Status | Terminated |
| Reason | A software anomaly that occurs when clinicians use Volume Vision to view images in 3D and uses the measurement tool to measure regions of interest. This could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan. |
| Root cause | Software design |
| Action | Philips sent an Urgent Field Safety Notice letter dated February 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to assure that all colleagues were aware of the problem. When using the Volume Vision software, check the correctness of measurements (graphics and numerical values) prior to saving a captured image containing measurements. Save captured images containing measurements immediately after creating them and before altering the measurements in the original image view. For any sub |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032096 | PHILIPS VIEWFORUM 2003 Philips Medical Systems, Jul 18, 2003 |