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Class 2 Device Recall CSM1901 |
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Date Initiated by Firm |
March 13, 2017 |
Date Posted |
March 20, 2017 |
Recall Status1 |
Terminated 3 on October 01, 2017 |
Recall Number |
Z-1768-2017 |
Recall Event ID |
76723 |
510(K)Number |
K151080
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Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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Product |
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). |
Code Information |
Lot/Unit Codes: G9 Serial Number: 230 (UDI: 01049319211121682100230) Serial Number: 232 (UDI: 01049319211121682100232) Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06, 02-10, or 02-40 software. Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower. |
Recalling Firm/ Manufacturer |
Nihon Kohden America Inc 15353 Barranca Pkwy Irvine CA 92618-2216
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For Additional Information Contact |
Thomas Bento 949-580-1555
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Manufacturer Reason for Recall |
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
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FDA Determined Cause 2 |
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 function on central monitors (models CNS 6201A and CNS 9701A; Software Versions 01-06, 02-10 and 02-40), will not automatically resume when connected to a Life Scope G9 patient monitor (model CSM 1901; versions 01-19, 01-20 and 01-21). Customers are informed of issue,risk to health, and instructions. Customers are instructed to complete the attached reply form and return it to the fax number or email address on the form. Customers with questions are instructed to contact NKA Technical Services Group at (800) 325-0283, Option 6 (M-F, 8am-5pm PDT) or by email at G9@nkusa.com. |
Quantity in Commerce |
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 |
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
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