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Nihon Kohden America Inc recalls Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) comm
Recalled April 19, 2017 · FDA recall Z-1768-2017 · Nihon Kohden America
Hazard
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor. · FDA Class II
Units
654 units total (230 units in US)
Sold at
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
Description
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Product
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).
Manufacturer(s)
Nihon Kohden America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →