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Class 2 Device Recall CNS6200 Series Central Nurse Station |
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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
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Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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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
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For Additional Information Contact |
949-580-1555
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = MHX and Original Applicant = NIHON KOHDEN CORP.
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