CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA recalled

Nihon Kohden America is recalling Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA, distributed nationwide in the US. The recall was initiated on 13 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/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.

Quantity recalled654 units total (230 units in US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1768-2017
FDA event ID: 76723
Recalling firm: Nihon Kohden America, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Mar 2017
FDA classified: 10 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

13 Mar 2017	Recall initiated by company
10 Apr 2017	Classified by FDA	+28 days
19 Apr 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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).

Where it was 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

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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