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) commu…

Recall date

March 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1768-2017

FDA classification

Class II

Brand / firm

Nihon Kohden America Inc

Sold / distributed

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

Why it was recalled

The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).