Recall Z-2268-2014— Ansar Group, Inc. Dba Ansar Medical Technologies, Inc

Name: FDA recall Z-2268-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-01

Class II · Terminated

Class II FDA medical device recall by Ansar Group, Inc. Dba Ansar Medical Technologies, Inc, initiated 2014-07-01, terminated 2015-08-10. It names one FDA 510(k) clearance: K941252. 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.. Reason: 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..

Recalling firm: Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-07-01
Terminated: 2015-08-10
Firm location: Philadelphia, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K941252 — RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSORAnsar·cleared 1995-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.