FDAFDA · Food and drugs·Recall number Z-2268-2014
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.
Published August 27, 2014 · Recall initiated: July 1, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
- Distributor
- Nationwide Distribution.
- Lot
- ANX 3.0 unit numbers: 193 through 1203.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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