[Recalled] 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure venti |
|---|---|
| Brand / manufacturer | ZOLL Medical Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0812-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 30 June 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from ZOLL Medical Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.