FDA recall Z-2340-2018

GE Healthcare Finland Oy · Class II · device

Product

GE Healthcare CARESCAPE Monitor B650

Reason for recall

When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

Distribution

worldwide

Key facts

Status: Ongoing
Initiation date: 2018-05-25
Report date: 2018-07-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Helsinki, Finland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2340-2018