DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS)
FDA device recall Z-0630-2013 · posted 2013-01-03 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Reason for recall
- There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
- Action taken
- Mindray sent a Product Corrective Action letter dated May 12, 2012, to all affected customers via certified mail return receipt requested to two medical facilities. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the issue would be corrected through a softweare upgrade of the affected product. A Mindray Service Representative would contact their facility to arrange for the software upgrade at no cost to them. For questions regarding this recall call 1-800-288-2121.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- two units
- Distribution
- Nationwide Distribution including OH and GA
- Date initiated
- 2011-05-12
- Date posted
- 2013-01-03
- Date terminated
- 2013-02-19
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) (K080192) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-04-03 |