FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)
- Recall number
- Z-1611-2014
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Product
- DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)
- Status
- Terminated
- Initiated
- 2014-03-05
- Posted
- 2014-05-13
- Terminated
- 2015-04-27
- Reason
- The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
- Root cause
- No Marketing Application
- Action
- Mindray DS Usa Inc. contacted their sole customer via phone on March 5, 2014. The affected products will receive software upgrade.
- Quantity
- 4 units
- Distribution
- US Nationwide Distribution in the state of OH
- Lot, serial or model codes
- monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876
- 510(k) numbers
- ["K092449"]
- PMA numbers
- not on file
- Product code
- MHX
- 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