Lower risk Medical device recall · FDA · Published October 1, 2019

Mindray Accutorr 3 Monitor Software Update Causes NIBP Valve Assembly Issues

Mindray recalls Accutorr 3 Vital Signs Monitors with specific software version 8.1.5 that may have NIBP valve assembly problems. Affected units could have unapproved software features that might cause hose blockages.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0235-2020Medical device Mindray ›

Lower-risk 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

Take action

Contact the company

Recalling firmMindray DS USA, Inc. dba Mindray North America800 Macarthur Blvd · Mahwah, NJ 07430-2001

✎ GovInfoNow plain-language explainer

Mindray is recalling Accutorr 3 Vital Signs Monitors with software version 8.1.5 that include an NIBP valve assembly board with unapproved software features. This could potentially cause NIBP hose blockages in healthcare settings. Read more at govinfonow.com/recall/66924-mindray-accutorr-3-monitor-software-update-causes-nibp-valve-assembly.

Source Summary by GovInfoNow · govinfonow.com/recall/66924-mindray-accutorr-3-monitor-software-update-causes-nibp-valve-assembly · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0235-2020

Cite this page

“Mindray Accutorr 3 Monitor Software Update Causes NIBP Valve Assembly Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66924-mindray-accutorr-3-monitor-software-update-causes-nibp-valve-assembly. Based on FDA recall #Z-0235-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0235-2020%22&limit=1).

Mindray DS USA, Inc. dba Mindray North America recalled the Accutorr 3 Vital Signs Monitor containing a specific NIBP valve assembly board software version on Oct. 1, 2019, according to the FDA. The device included enhancements not covered by current marketing clearance.

How to tell if you have it

Brand: Mindray
Product: Accutorr 3 Vital Signs Monitor with NIBP valve assembly board
Part number: p/n 115-017679-00
Software version: 8.1.5

The hazard

The recalled NIBP valve assembly board includes an anti-motion feature and an NIBP hose blockage identification function that are not included in the current marketing clearance.

Context

GovInfoNow's records show Mindray DS USA, Inc. dba Mindray North America has 13 other recalls on record since July 14, 2017. Other recent recalls of similar products include Medline Kits with B. Braun IV Sets Recalled for Check Valve Stuck Issue (Nov. 26, 2025), Medline Neuro Angio Pack Kits Recall: Check Valve Stuck in Open or Closed Position (Nov. 26, 2025), and Medline Recalls Open Heart Kits with Risk of Check Valve Sticking (Nov. 26, 2025).

How to tell if you have this one

Check for the Accutorr 3 Vital Signs Monitor with NIBP valve assembly board p/n 115-017679-00 and software version 8.1.5. The product is used in healthcare facilities for monitoring adult, pediatric, and neonatal patients.

Brand
Mindray
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide distributions.

Recall number	Product, codes & lots	Quantity
Z-0235-2020	Accutorr 3 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 spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians; NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5	13 units
Z-0236-2020	Accutorr 7 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; NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5	107 units
Z-0237-2020	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; NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5	14 units
Z-0238-2020	Rosebud 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 spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians; NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5	9 units

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your Accutorr 3 monitor's NIBP valve assembly board. If it shows version 8.1.5, it may be affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distributions.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Oct 1, 2019Firm started the recall
Oct 29, 2019FDA classified it Class II
Nov 6, 2019Published in FDA’s Enforcement Report
Aug 6, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66924-mindray-accutorr-3-monitor-software-update-causes-nibp-valve-assembly">Mindray Accutorr 3 Monitor Software Update Causes NIBP Valve Assembly Issues (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0235-2020 (October 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0235-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.