Class II — Mindray DS USA, Inc. dba Mindray North America
| Recalling firm | Mindray DS USA, Inc. |
|---|---|
| Registered facility | MINDRAY DS USA, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| 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 |
| Quantity | 14 units |
| Distribution | US Nationwide distributions. |
| Initiated | 2019-10-01 |
| Classified | 2019-10-29 |
| Terminated | 2021-08-06 |
| Recall number | Z-0237-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mindray DS USA, Inc. dba Mindray North America (Z-0237-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83979/
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