Mindray recalls Rosebud Vital Signs Monitors with software version 8.1.5 due to unapproved enhancements in the NIBP valve assembly board that may affect monitoring accuracy.
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 Rosebud Vital Signs Monitors with software version 8.1.5 because the NIBP valve assembly board contains enhancements not approved by regulators. This could lead to inaccurate blood pressure readings during use in healthcare settings.
The NIBP valve assembly board has software enhancements not included in the current marketing clearance. These unapproved features may cause the monitor to give incorrect blood pressure readings during use in healthcare settings.
Healthcare facilities using Mindray Rosebud Vital Signs Monitors with software version 8.1.5 are affected. Medical staff monitoring patients with these devices are most at risk of inaccurate readings.
Check for the Rosebud Vital Signs Monitor with NIBP valve assembly board, part number 115-017679-00, and software version 8.1.5. The device is intended for use in healthcare facilities by medical staff.
Verify the software version on your device; if it is 8.1.5, it is part of this recall.
The NIBP valve assembly board contains software enhancements not approved by regulators, which may cause inaccurate blood pressure readings.
The recall does not specify a remedy, so contact Mindray for guidance on next steps.
The device is safe for use in healthcare settings but may provide inaccurate readings due to unapproved software features.
We’ve drafted a message you can send Mindray to request your refund or repair — edit it as you like.
Subject: Recall Z-0238-2020 — Mindray Mindray Hello, I own a Mindray that is covered by recall Z-0238-2020 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.
