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U.S. Department of Health and Human Services

Class 2 Device Recall ANSAR ANX3.0 Autonomic Monitor system

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  Class 2 Device Recall ANSAR ANX3.0 Autonomic Monitor system see related information
Date Initiated by Firm July 01, 2014
Date Posted August 19, 2014
Recall Status1 Terminated 3 on August 10, 2015
Recall Number Z-2268-2014
Recall Event ID 68735
510(K)Number K941252  
Product Classification Monitor, cardiac (incl. Cardiotachometer and rate alarm) - Product Code DRT
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.
Code Information ANX 3.0 unit numbers: 193 through 1203.
Recalling Firm/
Manufacturer		 Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
240 S 8th St
Philadelphia PA 19107-5728
For Additional Information Contact Customer Support
215-922-6088
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRT and Original Applicant = ANSAR
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