Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended f
FDA device recall Z-0389-2014 · posted 2013-11-25 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue.
- Action taken
- Mindray sent an Urgent Corrective Action letter dated October 7, 2013 to all of their customers. The letter identified the affected product, problem and actions to be taken. Customers should contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday from 830 am to 530 pm to arrange for the replacement of the affected product.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 1839 units
- Distribution
- Worldwide Distribution - USA Nationwide
- Date initiated
- 2013-10-07
- Date posted
- 2013-11-25
- Date terminated
- 2015-04-27
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDEAVOUR MONITORING SYSTEM (K102004) | Mindray DS USA, Inc. | 2010-09-10 |