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Use caution Medical device recall · FDA · Published June 30, 2017

ZOLL 731 Ventilators Software Version 05.20.00 May Cause Unintended Settings Changes

ZOLL Medical recalls 731 Series Ventilators with software version 05.20.00 due to potential unintended device setting changes. Affected units may be used in hospitals, emergency care, and field settings for respiratory support.

🇺🇸 FDA recall #Z-0812-2018Medical deviceZOLL ›
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Recalling firmZOLL Medical Corporation269 & 271 Mill Road · Chelmsford, MA 01824
✎ GovInfoNow plain-language explainer

What happened, in plain English

ZOLL Medical is recalling 731 Series Ventilators running software version 05.20.00 because a software anomaly could cause users to accidentally change device settings. This poses a risk during critical medical situations where precise ventilator settings are necessary. Read more at govinfonow.com/recall/73484-zoll-731-ventilators-software-version-05-20-00-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/73484-zoll-731-ventilators-software-version-05-20-00-may-cause · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0812-2018

Cite this page

“ZOLL 731 Ventilators Software Version 05.20.00 May Cause Unintended Settings Changes.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73484-zoll-731-ventilators-software-version-05-20-00-may-cause. Based on FDA recall #Z-0812-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0812-2018%22&limit=1).

Why it’s dangerous

A software glitch in version 05.20.00 may cause users to inadvertently change ventilator settings. This could lead to incorrect respiratory support for patients during critical medical procedures, potentially causing harm if settings are not properly adjusted.

Who’s affected

Healthcare providers using ZOLL 731 Ventilators in hospitals, emergency medical services, or field settings are most at risk. Patients receiving ventilator support could be affected if settings are altered unintentionally.

How to tell if you have this one

Check if your ZOLL 731 Series Ventilator has software version 05.20.00. The devices are used in hospitals, emergency care, and field settings for respiratory support in patients weighing up to 5 kg with respiratory failure.

  • Brand
    ZOLL
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your ventilator's software version by checking the device display or manual.

  2. Update Software

    Contact ZOLL Medical to update to a corrected software version if your device is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Jun 30, 201712. FDA classified it Class II: Mar 1, 201823. Published in FDA’s Enforcement Report: Mar 7, 201834. FDA terminated the recall: Oct 9, 2018420172018
  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-0812-2018 (June 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0812-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 21, 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