Product Wiki · Recalls · U.S. FDA — Device Enforcement

Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. — recall Z-0523-2019

U.S. FDA — Device Enforcement · United States · 2018-08-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0523-2019
Date of alert
2018-08-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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