Z-2268-2014Class II

Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of...

Name: Z-2268-2014 Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of...
Creator: Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
Published: 2014-07-01
License: https://open.fda.gov/license/

Ansar Group, Inc. dba Ansar Medical Technologies, Inc / initiated 2014-07-01 / Terminated

FDA source

Ansar Group, Inc. Dba Ansar Medical Technologies, Inc began a recall of 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... on 2014-07-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2268-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-01
Posted: 2014-08-19
Terminated: 2015-08-10
Recalling firm: Ansar Group, Inc. dba Ansar Medical Technologies, Inc
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.
Product code: DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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.
FDA root cause: Unknown/Undetermined by firm
Action: Recall notification letters sent to customers on July 8-9, 2014 by registered mail.
Quantity in commerce: 351
Distribution: Nationwide Distribution.
Product codes and lots: ANX 3.0 unit numbers: 193 through 1203.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2268-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2268-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-19

Product code DRT

K941252Class IIRespiratory and Cardiac Spectral Frequency Signal ProcessorAnsar / cleared 1995-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)