FDA-Device2017-04-19Class II
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
Nihon Kohden America Inc
Hazard
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Sold states
Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand
Affected count
654 units total (230 units in US)
Manufactured in
15353 Barranca Pkwy, N/A, Irvine, CA, United States
Products
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2017Don't want to check this manually?
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