Cl II GE HEALTHCARE CARESCAPE software

Company:GE Medical Systems Information Technologies, Inc.
Date of Enforcement Report 27/2018
Class lI:

PRODUCT

GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information
Recall Number Z-0487-2018

REASON
CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.

RECALLING FIRM/MANUFACTURER
GE Medical Systems Information Technologies, Inc., Milwaukee, WI on 1/11/2018. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
1803 units

DISTRIBUTION
Nationwide and Internationally

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About the author

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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