Bedside monitor CSM-1901 — Class II medical device recall Z-1768-2017
Terminated recall by Nihon Kohden America Inc, reported 2017-04-19, distributed nationwide. The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient
| Recall number | Z-1768-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nihon Kohden America Inc, Irvine, CA, United States |
| Recall initiated | 2017-03-13 |
| Classified | 2017-04-10 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2017-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BO, BR, CL, CO, CR, DE, ES, IL, KR, MX, MY, PE, PK, PY, QA, SA, SG, TH, TN, ZA |
| Serial numbers | 230, 232 |
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).
Reason for recall
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1768-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.