Z-1979-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2014
- Initiation Date
- June 3, 2014
- Termination Date
- April 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 430
Product Description
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
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.
Distribution Pattern
Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.
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.