RecallRadar

FDA Device recall Z-2268-2014

Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system

On 2014-08-27 the FDA classified a Class II recall of Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system by Ansar Group, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2268-2014
ClassificationClass II
Statusterminated
Initiated2014-07-01
Published2014-08-27
Last updated2026-09-13 11:53 UTC
CompanyAnsar Group
DistributionUS

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.

Identifiers

code_infoANX 3.0 unit numbers: 193 through 1203.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2268-2014%22

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