Rosie4 Vital Signs Monitor with NIBP valve assembly board — Class II medical device recall Z-0237-2020
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2019-11-06, distributed nationwide. NIBP valve assembly board subject to this recall includes enhancements that are not included in the current ma
| Recall number | Z-0237-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2019-10-01 |
| Classified | 2019-10-29 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2021-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 14 units |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0237-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.