FDA Medical Device Recalls (openFDA)
Philips Medical Systems: 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 ; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA 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 number
- Z-1882-2011
- Recalling firm
- Philips Medical Systems
- Product
- 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 ; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA 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.
- Status
- Terminated
- Initiated
- 2011-02-23
- Posted
- 2011-04-04
- Terminated
- 2011-08-18
- 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 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.
- Quantity
- not on file
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- All units of these iSite PACS.
- 510(k) numbers
- ["K032096"]
- PMA numbers
- not on file
- Product code
- LLC
- Firm FEI
- 3002971142
- Firm city
- Foster City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28