V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use u
FDA device recall Z-2279-2012 · posted 2012-08-28 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Reason for recall
- Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012.
- Action taken
- Mindray sent an Urgent: V Series Monitoring System Correction letters dated May 7, 2012 via certified mail to all affect customer. The letter identified the affected product, problem and actions to be taken. Customers are directed that VPS modules should not be used between systems until a software upgrade has been completed. This work will be done at no cost to the customer. For questions contact your Mindray Serviice Representative at 1-800-288-2121.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 979 units
- Distribution
- Worldwide Distribution - US Nationwide including the states of: NY, SD, NE, IL, MO, CA, OH, OK, WA, IN, WY, CO, TX, FL, NC, AL and Puerto Rico. and the countries of: Australia, Canada, Columbia, New Z
- Date initiated
- 2012-05-07
- Date posted
- 2012-08-28
- Date terminated
- 2013-07-17
- 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 |