Nihon Kohden CNS-6201 Central Nurse Station Software Recall
Nihon Kohden is recalling CNS-6201 Central Nurse Stations with software version 02-26 due to unexpected reboots that interrupt patient data display and alarms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software defect causes a temporary loss of monitoring and alarm functions, representing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Nihon Kohden America Inc is recalling 430 units of the CNS-6200 Series Central Nurse Station, specifically model CNS-6201, equipped with software version 02-26. The recall affects units distributed in Oklahoma and in Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.
The recall is issued because the software may cause the system to unexpectedly reboot without warning. During the reboot period, which lasts approximately three minutes, the system does not display patient data and does not emit alarms based on that data, even if they are appropriate.
Healthcare facilities should identify affected units by checking for model number CNS-6201, software version 02-26, and the specific serial numbers listed in the recall notice. Users should contact Nihon Kohden America Inc for instructions on how to resolve the issue.
The recalled product
- Product
- CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
- Manufacturer
- Nihon Kohden America Inc
- Affected units
- 430
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 1 state:
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