Recall Z-1768-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Nihon Kohden America Inc
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).
| Date | Mar 20, 2017 (initiated Mar 13, 2017) |
| Status | Terminated |
| Reason | The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor. |
| Root cause | Nonconforming Material/Component |
| Action | A technical bulletin was issued on March 7, 2017 to make Life Scope G9 users aware of following interaction: the CNS 6201A and CNS 9701A (using the noted software versions) will not Auto Resume when a patient is reconnected to a Life Scope G9 if the patient tile is Paused. Therefore, each time a patient is reconnected to the Life Scope G9, the Pause must be cancelled and monitoring manually resumed on the CNS 6201A or CNS 9701A. A customer letter dated March 13, 2017 was sent to all customers to inform them that Nihon Kohden America (NKA) is voluntarily notifying them that the Pause functio |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151080 | Nihon Kohden CSM 1901 Bedside Monitor Nihon Kohden, Nov 5, 2015 |