FDA-Device2018-07-11Class II
GE Healthcare CARESCAPE Monitor B650
GE Healthcare Finland Oy
Hazard
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.
Sold states
worldwide
Affected count
69231 units
Manufactured in
Kuortaneenkatu 2, Helsinki, Finland
Products
GE Healthcare CARESCAPE Monitor B650
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2340-2018Don't want to check this manually?
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