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Terminated

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 Recall Z-1881-2011 · Posted 2011-04-04

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeLLC
Date Initiated2011-02-23
Date Terminated2011-08-18

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063267ISITE PACS, V 4. XStentor Inc., A Philips Medical Systems Co. · 2006-11-09K042292ISITE PACSStentor, Inc. · 2004-09-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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