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Recall Observatory FDA recall evidence

Device 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).

Z-1768-2017

March 13, 2017

Class II

Product summary

Firm
Nihon Kohden America Inc
Event
Event 76723
Status
Terminated
Classification
Class II
Quantity
654 units total (230 units in US)
Official record key
device-enforcement:Z-1768-2017

Official wording

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

Code information: Lot/Unit Codes: G9 Serial Number: 230 (UDI: 01049319211121682100230) Serial Number: 232 (UDI: 01049319211121682100232) Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06, 02-10, or 02-40 software. Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower.

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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