Mindray recalls Accutorr 7 monitors with software version 8.1.5 due to unapproved enhancements in NIBP valve assembly board that may cause inaccurate blood pressure readings.
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 Accutorr 7 Vital Signs Monitors with specific software and hardware that include unapproved features. These changes could lead to inaccurate blood pressure readings, which is important for medical monitoring.
The NIBP valve assembly board in these monitors has software enhancements not approved by regulatory authorities. These unapproved features may cause the monitor to give inaccurate blood pressure readings during use.
Healthcare professionals using the Accutorr 7 monitors with the specified software version and hardware model are affected. Patients receiving blood pressure monitoring via this equipment are at risk of inaccurate readings.
Check for the Accutorr 7 Vital Signs Monitor with NIBP valve assembly board part number 115-017679-00 and software version 8.1.5. The product is sold in professional healthcare facilities.
Verify the software version on your monitor; if it is 8.1.5, it is part of this recall.
Reach out to Mindray North America for guidance on next steps.
The NIBP valve assembly board includes software enhancements not approved by regulatory authorities, which could lead to inaccurate blood pressure readings.
No, the recall does not require immediate discontinuation; users should check the software version and contact Mindray for guidance.
Check the software version and contact Mindray North America for specific instructions.
We’ve drafted a message you can send Mindray to request your refund or repair — edit it as you like.
Subject: Recall Z-0236-2020 — Mindray Mindray Hello, I own a Mindray that is covered by recall Z-0236-2020 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.
