Recall Z-0585-2019— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.. Reason: Patient monitors may restart due to network overload caused by network configuration..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-09-11
- Firm location
- Waukesha, WI, United States
Product description
B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
Reason for recall
Patient monitors may restart due to network overload caused by network configuration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.