Company: Ansar Group, Inc.
Date of Enforcement Report: 8/27/2014
Class lI:
PRODUCT
blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of a number of components. The components are the following: 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.
Recall Number Z-2268-2014
REASON
Ansar Group, Inc. recalled the blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system because of complaints that it occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.
RECALLING FIRM/MANUFACTURER
Ansar Group, Inc. Dba Ansar Medical Technologies, Inc, Philadelphia, PA on 7/1/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
351
DISTRIBUTION
Nationwide
___________________________________
