Recall Z-1881-2011 ยท LLC
Philips Medical Systems
iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package use
| 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 |