FDA Medical Device Recalls (openFDA)
Philips Medical Systems: Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169
- Recall number
- Z-1182-2007
- Recalling firm
- Philips Medical Systems
- Product
- Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169
- Status
- Terminated
- Initiated
- 2007-07-16
- Posted
- 2007-09-05
- Terminated
- 2016-08-01
- Reason
- Incorrect Patient Assignment: the information center will in most cases be associated with the "incorrect" patient. This occurs on both standalone and networked systems running fixed mode monitoring. (This does not occur on systems that run flex mode monitoring)
- Root cause
- Other
- Action
- Philips Medical Systems issued a letter notification dated July 2007 " Urgent Device Correction". Customers with networked information centers will be corrected through a database server. Stand-Alone units will have a software correction. Software version J.00.25 will correct the problem. Users are advised not to use th 12 Lead Analysis and Export Option in fixed or flex mode monitoring unitl the software correction is made.
- Quantity
- 76 units
- Distribution
- Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK
- Lot, serial or model codes
- Software versions: J.00.23 and J.00.24 (You can determine the application software release as follows: 1-Enter Service Mode through "All Controls" , "Service" 2-Under the "Other Services " menu item, click "Software Versions" 3-"Application" lists the application software version.
- 510(k) numbers
- ["K062271"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- 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