Company: General Electric Medical Systems Information Technology
Date of Enforcement Report: 3/31/04
Class: II
PRODUCT
PatientNet Monitoring System – PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx. Recall # Z-0727-04.
REASON
Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.
CODE
All PatientNet Central Stations.
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on February 27, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
574 software units.
DISTRIBUTION
Nationwide.
