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