FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1979-2014
- Recalling firm
- Nihon Kohden America Inc
- Product
- CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
- Status
- Terminated
- Initiated
- 2014-06-03
- Posted
- 2014-07-02
- Terminated
- 2015-04-28
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K102376"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2080783
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28