Mar

2004

GE Medical Systems Information Technology Class II

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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GE Medical Systems Information Technology Class II

Amy Sellers

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