Z-1768-2017 Class II Terminated
FDA device recall Z-1768-2017 was initiated by Nihon Kohden America Inc on March 13, 2017 and is designated Class II. Reason for recall: The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor. The recall status is terminated (terminated October 1, 2017). Affected quantity: 654 units total (230 units in US).
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 13, 2017
- Termination Date
- October 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 654 units total (230 units in US)
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.
Distribution Pattern
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
Code Information
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.