FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
- Recall number
- Z-0235-2020
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Product
- Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
- Status
- Terminated
- Initiated
- 2019-10-01
- Posted
- not on file
- Terminated
- 2021-08-06
- Reason
- NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function
- Root cause
- No Marketing Application
- Action
- Mindray communicated by letter on 10/1/19 to consignees and distributors by certified postal mail with return receipt verification: to consignees that have affected vital sign monitor; communication to consignees that purchased directly NIBP valve assembly boards; communication to distributors that have affected vital sign monitor. Consignees were instructed to contact Mindrays Repair Center to arrange for affected units to be returned for a software update.
- Quantity
- 13 units
- Distribution
- US Nationwide distributions.
- Lot, serial or model codes
- NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5
- 510(k) numbers
- ["K132037"]
- 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