FDA Medical Device Recalls (openFDA)
Philips Healthcare Informatics, Inc.: Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
- Recall number
- Z-2252-2014
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Product
- Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
- Status
- Terminated
- Initiated
- 2014-07-24
- Posted
- 2014-08-16
- Terminated
- 2016-02-11
- Reason
- A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
- Root cause
- Software design
- Action
- Urgent Medical Device Correction was sent to all affected sites on July 24, 2014 by certified mail.
- Quantity
- 109 units
- Distribution
- US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
- Lot, serial or model codes
- IntelliSpace 4.4
- 510(k) numbers
- ["K111804"]
- PMA numbers
- not on file
- Product code
- LLZ
- 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