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.
Recall
- Recall Number
- Z-2268-2014
- Event Number
- 68735
- Firm
- Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
- FEI Number
- 3000210032
- Product Code
- DRT
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- July 1, 2014
- Posted
- August 19, 2014
- Terminated
- August 10, 2015
- Address
- 240 S 8th St, Philadelphia, PA, 19107-5728
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.
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.
Recall notification letters sent to customers on July 8-9, 2014 by registered mail.
Nationwide Distribution.
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