731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management o...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0812-2018.
A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0812-2018.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Zoll Medical Corporation or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0812-2018.
ZOLL Medical Corporation
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Zoll Medical Corporation Recall FAQ
Zoll Medical Corporation is the subject of a medical implants safety report: 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management o.... The notice was published on June 30, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 46 units are potentially affected.