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U.S. Department of Health and Human Services

Class 2 Device Recall iSite PACS with Advanced Visualization Tools (AVT)

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  Class 2 Device Recall iSite PACS with Advanced Visualization Tools (AVT) see related information
Date Initiated by Firm February 23, 2011
Date Posted April 04, 2011
Recall Status1 Terminated 3 on August 18, 2011
Recall Number Z-1881-2011
Recall Event ID 58044
510(K)Number K042292  K063267  
Product Classification System, image processing, radiological - Product Code LLC
Product 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 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.

Code Information All units of these iSite PACS.
Recalling Firm/
Manufacturer		 Philips Medical Systems
4100 E 3rd Ave Ste 101
Foster City CA 94404-4819
For Additional Information Contact Victoria Mackinnon
650-293-2624
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 subsequent measurements, create a new capture and save it immediately. For further information or support concerning this issues, customers should contact their local Philips representative at +1-877-328-2808.
Distribution Worldwide Distribution.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLC and Original Applicant = STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO.
510(K)s with Product Code = LLC and Original Applicant = STENTOR, INC.
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