Recall Z-1979-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Nihon Kohden America Inc
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
| Date | Jul 2, 2014 (initiated Jun 3, 2014) |
| Status | Terminated |
| Reason | Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate. |
| Root cause | Software design |
| Action | Nihon Kohden sent an Urgent Medical Device Safety Notification and Field Correction letter dated June 3, 2014 to affected customers. Recall notification letter, dated June 3, 2014 was hand-delivered to site by Nihon personnel. The letter provided the following information: product description with codes and software version, reason for recall, field correction information and actions to be taken, MedWatch reporting information, and contact information for recall. |
| Quantity | 430 |
| Distribution | Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102376 | NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 Nihon Kohden Corp., Dec 7, 2010 |