Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these comp
FDA device recall Z-2268-2014 · posted 2014-08-19 · Terminated
Recall details
- Recalling firm
- Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
- 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.
- Action taken
- Recall notification letters sent to customers on July 8-9, 2014 by registered mail.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- DRT
- Quantity affected
- 351
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-07-01
- Date posted
- 2014-08-19
- Date terminated
- 2015-08-10
- Location
- Philadelphia, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR (K941252) | Ansar | 1995-09-20 |