CNS-6200 Series Central Nurse Station and accessories recall: Software Issue
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Why was CNS-6200 Series Central Nurse Station and accessories recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
- Recalling firm
- Nihon Kohden America Inc
- 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.
- Recall date
- July 9, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)