Recall Z-0237-2020— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-0237-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-01

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2019-10-01, terminated 2021-08-06. It names one FDA 510(k) clearance: K170712. Product: Rosie4 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 monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. 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.

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2019-10-01
Terminated: 2021-08-06
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K170712 — Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.·cleared 2017-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Rosie4 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 monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.