Z-2268-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2014
- Initiation Date
- July 1, 2014
- Termination Date
- August 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 351
Product Description
Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000.
Reason for Recall
The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.
Distribution Pattern
Nationwide Distribution.
Code Information
ANX 3.0 unit numbers: 193 through 1203.