FDA Medical Device Recalls (openFDA)
Philips Medical Systems Nederlands: Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device.
- Recall number
- Z-1125-2012
- Recalling firm
- Philips Medical Systems Nederlands
- Product
- Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device.
- Status
- Terminated
- Initiated
- 2012-01-27
- Posted
- 2012-02-29
- Terminated
- 2021-02-25
- Reason
- There maybe incorrect values in the diffusion/perfusion maps.
- Root cause
- Software design
- Action
- Philips issued URGENT - Medical Device Correction Notifications, dated January 20, 2012. The letter identified the affected product, all Intellispace Portal with software release 4.0.0 Installed, and gave a description of the problem. Users were provided with the actions to be taken prior to the software upgrade( to version 4.0.1). Users are to follow the instructions provided in order to generate maps with the correct values and to make sure that the setting is correct before using the generated data. Philips will contact customers in order to install the update free of charge. Customers should contact their local Philips representative at 866-767-2822
- Quantity
- 25 units
- Distribution
- Worldwide Distribution -- US, including states of IN and TX, and countries of Australia, Austria, Czech, Denmark, France, Germany, Indonesia, Netherlands, Poland, Spain, and Switzerland.
- Lot, serial or model codes
- Software release 4.0.0
- 510(k) numbers
- ["K003853","K110151"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3002807880
- Firm city
- Best
- Firm state
- not on file
- Firm country
- Netherlands
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