Recall Z-1768-2017— Nihon Kohden America Inc
Class II · Terminated
Class II FDA medical device recall by Nihon Kohden America Inc, initiated 2017-03-13, terminated 2017-10-01. It names one FDA 510(k) clearance: K151080. 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..
- Recalling firm
- Nihon Kohden America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-13
- Terminated
- 2017-10-01
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Reason for recall
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.