FDA Device recall Z-2268-2014
Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system
- FDA Device
- Class II
- terminated
- Published 2014-08-27
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2268-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-01 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ansar Group |
| Distribution | US |
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_info | ANX 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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