PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.
FDA device recall Z-0727-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- General Electric Medical Systems Information Technology
- Reason for recall
- Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- Undetermined a this time. 574 sofware units were distributed with ability to upgrade one or multiple devices.
- Distribution
- Nationwide throughout the United States
- Date initiated
- 2004-02-27
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-17
- Location
- Milwaukee, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PATIENTNET MONITORING SYSTEM (K020524) | General Electric Medical Systems Information Techn | 2002-03-20 |