FDA Medical Device Recalls (openFDA)
Ansar Group, Inc. Dba Ansar Medical Technologies, Inc: 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 number
- Z-2268-2014
- 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.
- Status
- Terminated
- Initiated
- 2014-07-01
- Posted
- 2014-08-19
- Terminated
- 2015-08-10
- 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.
- Root cause
- Unknown/Undetermined by firm
- Action
- Recall notification letters sent to customers on July 8-9, 2014 by registered mail.
- Quantity
- 351
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- ANX 3.0 unit numbers: 193 through 1203.
- 510(k) numbers
- ["K941252"]
- PMA numbers
- not on file
- Product code
- DRT
- Firm FEI
- 3000210032
- Firm city
- Philadelphia
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28