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).
Reported: April 19, 2017 Initiated: March 13, 2017 #Z-1768-2017
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.
Details
- Recalling Firm
- Nihon Kohden America Inc
- Units Affected
- 654 units total (230 units in US)
- Distribution
- 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
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Nihon Kohden America Inc. Units affected: 654 units total (230 units in US).
Why was this product recalled? ▼
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2017. Severity: Moderate. Recall number: Z-1768-2017.
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