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
FDA Recall Z-0237-2020 · Posted None
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Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeMWI
Date Initiated2019-10-01
Date Terminated2021-08-06
Product Quantity14 units
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
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
US Nationwide distributions.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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