Mindray recalls Rosie4 Vital Signs Monitors with software version 8.1.5 due to potential NIBP hose blockage. Affected units have specific part numbers and were sold in professional healthcare settings.
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
Mindray is recalling Rosie4 Vital Signs Monitors with software version 8.1.5 because the NIBP valve assembly board includes features not approved by regulators. This could lead to NIBP hose blockages in medical use, potentially affecting patient monitoring.
The NIBP valve assembly board in the recalled software version includes enhancements like anti-motion features and NIBP hose blockage identification that were not approved by regulators. These changes could cause the blood pressure monitoring hose to become blocked during use, potentially disrupting patient monitoring.
Healthcare facilities using Mindray Rosie4 monitors with software version 8.1.5 and part number 115-017679-00 are most at risk. Patients in professional medical settings using these monitors may be affected.
Check if your Rosie4 Vital Signs Monitor has software version 8.1.5 and part number 115-017679-00. These units were sold in professional healthcare facilities for patient monitoring.
Verify your monitor's software version is 8.1.5 and part number 115-017679-00.
The NIBP valve assembly board includes features not approved by regulators, such as anti-motion and NIBP hose blockage identification, which could cause monitoring issues.
The recall record does not specify a remedy, so no action is required beyond checking if your monitor matches the described version and part number.
The recall indicates potential NIBP hose blockages, but the record does not specify if this causes serious injury or requires immediate action.
We’ve drafted a message you can send Mindray to request your refund or repair — edit it as you like.
Subject: Recall Z-0237-2020 — Mindray Mindray Hello, I own a Mindray that is covered by recall Z-0237-2020 from Mindray. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
