Company:Nihon Kohden America, Inc
Date of Enforcement Report 4/192017
Class lI:
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).
Recall Number Z-1768-2017
REASON
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
RECALLING FIRM/MANUFACTURER
Nihon Kohden America, Inc., Irvine, CA on 3/13/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
654 units total (230 units in US)
DISTRIBUTION
Nationwide and Internationally
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