Reported Apr 19, 2017 · Terminated
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9)…
Nihon Kohden America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nihon Kohden America Inc · 15353 Barranca Pkwy · Irvine, CA · 92618-2216
Is this the product you have?
- 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).
- Lot codes and dates
- Lot/Unit CodesG9
- Serial Number230 (UDI: 01049319211121682100230)
- Serial Number232 (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
- Amount recalled
- 654 units total (230 units in US)
Where it was sold
- Nationwide
Why it was recalled
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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