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Lower risk Medical device recall · FDA · Published July 14, 2017

Mindray A7 Anesthesia System Software Issue May Cause Incorrect Settings

Mindray recalls A7 Anesthesia Delivery System model 0632F-PA0000X (2013-2016) due to software error potentially skipping startup leak test. Affected units may apply wrong settings during anesthesia delivery.

🇺🇸 FDA recall #Z-0847-2018Medical deviceMindray ›
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Contact the company

Recalling firmMindray DS USA, Inc. dba Mindray North America800 Macarthur Blvd · Mahwah, NJ 07430-2001
✎ GovInfoNow plain-language explainer

What happened, in plain English

Mindray is recalling its A7 Anesthesia Delivery System (model 0632F-PA0000X) because a software issue could cause the device to skip the startup leak test or use previous settings instead of default settings. This could lead to incorrect anesthesia delivery during medical procedures. Read more at govinfonow.com/recall/73414-mindray-a7-anesthesia-system-software-issue-may-cause-incorrect-settings.

Source Summary by GovInfoNow · govinfonow.com/recall/73414-mindray-a7-anesthesia-system-software-issue-may-cause-incorrect-settings · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0847-2018

Cite this page

“Mindray A7 Anesthesia System Software Issue May Cause Incorrect Settings.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73414-mindray-a7-anesthesia-system-software-issue-may-cause-incorrect-settings. Based on FDA recall #Z-0847-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0847-2018%22&limit=1).

Why it’s dangerous

The software issue may cause the device to skip the startup leak test or apply previous settings instead of default settings. This could lead to incorrect anesthesia delivery if the device fails to properly check for leaks before use.

Who’s affected

Healthcare facilities that purchased or upgraded the A7 Anesthesia System between March 2013 and December 21, 2016 are likely affected. Licensed clinicians using this system for anesthesia in adults, children, and infants are at risk.

How to tell if you have this one

Check for model number 0632F-PA0000X on the device. Units were distributed or upgraded between March 2013 and December 21, 2016. Serial numbers are required for verification.

  • Brand
    Mindray
  • Category
    Medical device
FDA recall event · 2 products

All 2 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
    Worldwide Distribution - US Nationwide
Recall numberProduct, codes & lots
Z-0846-2018A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.; Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
Z-0847-2018A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.; Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Mindray North America for verification and instructions on next steps.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Jul 14, 201712. FDA classified it Class II: Mar 2, 201823. Published in FDA’s Enforcement Report: Mar 14, 201834. FDA terminated the recall: Apr 17, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0847-2018 (July 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0847-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 20, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA