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Ansar Group, Inc. Dba Ansar Medical Technologies, Inc recalls Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these
Recalled August 27, 2014 · FDA recall Z-2268-2014 · Ansar Group, Inc.
Hazard
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. · FDA Class II
Units
351
Sold at
Nationwide Distribution.
Description
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.
Product
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.
Manufacturer(s)
Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →