Recall Z-2268-2014 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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 p
| Date | Aug 19, 2014 (initiated Jul 1, 2014) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941252 | RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR Ansar, Sep 20, 1995 |