FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. d.b.a. Mindray North America: Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
- Recall number
- Z-0742-2013
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Product
- Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
- Status
- Terminated
- Initiated
- 2012-09-05
- Posted
- 2013-01-27
- Terminated
- 2013-10-22
- Reason
- Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
- Root cause
- Device Design
- Action
- Mindray DS USA Inc. sent an Urgent Product Corrective Action letter on September 5, 2012 via Fed Ex with delivery confirmation to all users. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday 8:30-5:30 pm, to schedule a software upgrade.
- Quantity
- 13 units
- Distribution
- US Nationwide Distribution including the states of: VA, TN, FL, & TX
- Lot, serial or model codes
- p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373
- 510(k) numbers
- ["K053234"]
- PMA numbers
- not on file
- Product code
- MWI
- 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