Company: Philips Medical Systems, Inc.
Date of Enforcement Report 4/13/2011
Class ll:
PRODUCT
1) iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; 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 used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems. Recall # Z-1881-2011
2) 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; 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 “off-the-shelf” standard computer components. iSite ViewForum Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. iSite ViewForum Applications performs viewing, image manipulation, communication, printing, and quantification of images. Recall # Z-1882-2011
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..
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, Foster City, CA, by letter dated February 23, 2011.
Manufacturer: Philips Healthcare Informatics, Inc., Foster City, CA. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
144 units
DISTRIBUTION
Nationwide and Internationally
