Reported Aug 27, 2014 · Terminated
Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these…
Ansar Group, Inc. dba Ansar Medical Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ansar Group, Inc. Dba Ansar Medical Technologies, Inc · 240 S 8th St · Philadelphia, PA · 19107-5728
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
| — | Patient Physiological Monitor |
| — | Laptop Computer |
| — | Stand w/wheels |
| — | Patient cables |
405P | 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 , Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000. |
- Lot codes and dates
- ANX 3.0
- unit numbers193 through 1203
- Amount recalled
- 351
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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