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.
FDA Recall Z-2268-2014 · Posted 2014-08-19
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Recalling FirmAnsar Group, Inc. Dba Ansar Medical Technologies, Inc
Recall StatusTerminated
Product CodeDRT
Date Initiated2014-07-01
Date Terminated2015-08-10
Product Quantity351
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.
Firm Action
Recall notification letters sent to customers on July 8-9, 2014 by registered mail.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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