| ||Class 2 Device Recall CNS6200 Series Central Nurse Station |
||July 02, 2014
||Terminated on April 28, 2015
|Recall Event ID
Monitor, physiological, patient(with arrhythmia detection or alarms) -
||CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201
For cardiac and vital signs monitoring for multiple patients.
||Model Number: CNS-6201
Software Version 02-26 only.
Nihon Kohden America Inc
15353 Barranca Pkwy
|For Additional Information Contact
|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.
||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 in Commerce
||Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = MHX and Original Applicant = NIHON KOHDEN CORP.