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U.S. Department of Health and Human Services

Class 2 Device Recall CNS6200 Series Central Nurse Station

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  Class 2 Device Recall CNS6200 Series Central Nurse Station see related information
Date Initiated by Firm June 03, 2014
Date Posted July 02, 2014
Recall Status1 Terminated 3 on April 28, 2015
Recall Number Z-1979-2014
Recall Event ID 68459
510(K)Number K102376  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201

For cardiac and vital signs monitoring for multiple patients.
Code Information Model Number: CNS-6201  Software Version 02-26 only. Serial Numbers: 00485,  00488,  00489,  00490,  00491,  00361,  00429,  00430, 00432,  00436,  00443,  00447,  00478,  00486,  00546,  00564,  00573,  00574,  00575,  00576,  00592,  00626, 00638, 00643,  00651,  00674,  00675,  00677,  00678, 00679, 00687.
Recalling Firm/
Manufacturer		 Nihon Kohden America Inc
15353 Barranca Pkwy
Irvine CA 92618-2216
For Additional Information Contact
949-580-1555
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = NIHON KOHDEN CORP.
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