FDA Device recall Z-1768-2017
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-62…
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-62… by Nihon Kohden America, citing the Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1768-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-13 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nihon Kohden America |
| Distribution | US |
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
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Identifiers
| code_info | Lot/Unit Codes: G9 Serial Number: 230 (UDI: 01049319211121682100230) Serial Number: 232 (UDI: 01049319211121682100232…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Nihon Kohden America
- Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03,…
FDA Device · Class II · 2026-10-14 · Nihon Kohden America - Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who ca…
FDA Device · Class II · 2024-11-13 · Nihon Kohden America - Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
FDA Device · Class II · 2024-11-06 · Nihon Kohden America - Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp
FDA Device · Class II · 2024-11-06 · Nihon Kohden America - BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and…
FDA Device · Class II · 2024-06-12 · Nihon Kohden America
All Nihon Kohden America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1768-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.