DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, st
FDA device recall Z-1611-2014 · posted 2014-05-13 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
- Action taken
- Mindray DS Usa Inc. contacted their sole customer via phone on March 5, 2014. The affected products will receive software upgrade.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 4 units
- Distribution
- US Nationwide Distribution in the state of OH
- Date initiated
- 2014-03-05
- Date posted
- 2014-05-13
- Date terminated
- 2015-04-27
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 (K092449) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-08-30 |