Recall – Patient Monitoring System software error

Company: GE Healthcare, LLC
Date of Enforcement Report: 11/29/2018
Class II:

PRODUCT
Patient Monitoring System used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

Recall Number: Z-0519-2019 (Dash 3000), Z-0520-2019 (Dash 4000), Z-0521-2019 (Dash 5000), Z-0522-2019 (Solar 8000i), Z-0523-2019 (Solar 8000M), Z-0524-2019 (Solar 9500)

REASON
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 8/31/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
– Approximately 182,640 monitoring systems for Dash 3000/4000/5000

– Approximately 73,673 Solar 8000i and 8000M monitoring systems

– Approximately 3,864 Solar 9500 monitoring systems

DISTRIBUTION
U.S. Nationwide and International

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.