Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2019 - (Recall #: Z-0237-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 1, 2019

Date Posted: November 6, 2019

Recall Number: Z-0237-2020

Event ID: 83979

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

Status: Terminated

Product Quantity: 14 units

Code Information:

NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5

Distribution Pattern:

US Nationwide distributions.

Voluntary or Mandated:

Voluntary: Firm initiated