Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.

FDA Recall Z-1750-2015 · Posted 2015-06-10

Recalling FirmResMed Ltd.
Recall StatusTerminated
Product CodeCBK
Date Initiated2015-05-05
Date Terminated2016-04-07
Product Quantity1519 units

Reason for Recall

The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm.

Firm Action

A customer notification letter dated 5/5/15 will be sent to customers that the Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. The letter provides the customers with the hazards involved and the actions to be taken. Customers are instructed to ensure alarms are appropriately set up for ventilator dependent patients. Customers with questions are instructed to contact Larissa D'Andrea at (858) 836-6837 or email larissa.d'[email protected].

Root Cause

Use error

Distribution Pattern

Worldwide distribution. US nationwide, Uruguay and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑