FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.
- Recall number
- Z-0837-2015
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Product
- DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.
- Status
- Terminated
- Initiated
- 2014-10-06
- Posted
- 2014-12-19
- Terminated
- 2017-06-06
- Reason
- Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.
- Root cause
- Process control
- Action
- Mindray DS USA, Inc. sent an Urgent Field Corrective Action Letter dated 10/6/2014 to their customers via certified mail with return receipt. The letter identified the affected product, the problem, adverse effects on the patient, and corrective actions. Customers are asked to either verify that the IBP modules are not affected by following the steps provided in the "Procedures for Verifying IBP Channel Connections;" or to discontinue use of the IBP modules until a Mindray Service Representative contacts them and performs the test to verify the function of the IBP modules. Customers are to contact their local Mindray Service Representative at 1-800-288-2121 to inform them of which corrective action will be taken. Questions should be directed to Diane Arpino at 201-995-8407 or d.arpino@mindray.com.
- Quantity
- 455 units
- Distribution
- Distributed to the states of AL, CA, CO, FL, GA, IA, IL, IN, LA. MA, MO, MS, MT, NC, ND, NY, OH, PA, SC, TX, VA, WA and WV.
- Lot, serial or model codes
- DPM 6 - PN: C-047-000199-00 and DPM 7 - PN: C-047-000200-00, IBP Module P/N: 6800-30-50485
- 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