—#98095

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.

FDA product code: LLC
510(k) numbers: K042292, K063267
Affected lot / code info: All units of these iSite PACS.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems
Address: 4100 E 3rd Ave, Ste 101, Foster City, California 94404-4819

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2011-02-23
Posted by FDA: 2011-04-04
Terminated: 2011-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98095. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.