FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. d.b.a. Mindray North America: DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
- Recall number
- Z-0630-2013
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Product
- DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
- Status
- Terminated
- Initiated
- 2011-05-12
- Posted
- 2013-01-03
- Terminated
- 2013-02-19
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- two units
- Distribution
- Nationwide Distribution including OH and GA
- Lot, serial or model codes
- 510 K K080192 P/N 300BF-PA200002
- 510(k) numbers
- ["K080192"]
- PMA numbers
- not on file
- Product code
- MSX
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28