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
- Recall Number
- Z-0235-2020
- Event Number
- 83979
- Firm
- Mindray DS USA, Inc. dba Mindray North America
- FEI Number
- 2221819
- Product Code
- MWI
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- October 1, 2019
- Terminated
- August 6, 2021
- Address
- 800 Macarthur Blvd, Mahwah, NJ, 07430-2001
Description
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
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
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.
US Nationwide distributions.
13 units