Class 2 Device Recall Rosebud Vital Signs Monitor

• Date Initiated by Firm: October 01, 2019
• Create Date: October 29, 2019
• Recall Status: Terminated on August 06, 2021
• Recall Number: Z-0238-2020
• Recall Event ID: 83979
• 510(K)Number: K132037
• Product Classification: Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
• Product: Rosebud 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
• Code Information: NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5
• FEI Number: 2221819
• Recalling Firm/ Manufacturer: Mindray DS USA, Inc. dba Mindray North America; 800 Macarthur Blvd; Mahwah NJ 07430-2001
• For Additional Information Contact: SAME; 800-288-2121
• Manufacturer 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
• FDA Determined 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 in Commerce: 9 units
• Distribution: US Nationwide distributions.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MWI