FDA Medical Device Recalls (openFDA)
General Electric Medical Systems Information Technology: PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.
- Recall number
- Z-0727-04
- Recalling firm
- General Electric Medical Systems Information Technology
- Product
- PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.
- Status
- Terminated
- Initiated
- 2004-02-27
- Posted
- 2004-07-20
- Terminated
- 2005-11-17
- Reason
- Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.
- Root cause
- Other
- Action
- Consignees were notified via certified mail, return receipt requested, on Friday, February 27, 2004. GE Field service representatives will upgrade affected PatientNet Central Stations (RVS, IRVS, or Sitelink IRVS) to software version 2.01.
- Quantity
- Undetermined a this time. 574 sofware units were distributed with ability to upgrade one or multiple devices.
- Distribution
- Nationwide throughout the United States
- Lot, serial or model codes
- All PatientNet Central Stations
- 510(k) numbers
- ["K020524"]
- PMA numbers
- not on file
- Product code
- MSX
- Firm FEI
- 2124823
- Firm city
- Milwaukee
- Firm state
- WI
- 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