Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
FDA device recall Z-0742-2013 · posted 2013-01-27 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Reason for recall
- Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
- Action taken
- Mindray DS USA Inc. sent an Urgent Product Corrective Action letter on September 5, 2012 via Fed Ex with delivery confirmation to all users. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday 8:30-5:30 pm, to schedule a software upgrade.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 13 units
- Distribution
- US Nationwide Distribution including the states of: VA, TN, FL, & TX
- Date initiated
- 2012-09-05
- Date posted
- 2013-01-27
- Date terminated
- 2013-10-22
- 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 |
|---|---|---|
| PM-9000 EXPRESS PATIENT MONITOR (K053234) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-05-04 |