Nihon Kohden America Inc: Medical Device Recall in 2017 - (Recall #: Z-1768-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: March 13, 2017

Date Posted: April 19, 2017

Recall Number: Z-1768-2017

Event ID: 76723

Reason for Recall:

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

Status: Terminated

Product Quantity: 654 units total (230 units in US)

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

Voluntary or Mandated:

Voluntary: Firm initiated