Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
FDA device recall Z-1750-2015 · posted 2015-06-10 · Terminated
Recall details
- Recalling firm
- ResMed Ltd.
- 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.
- Action taken
- 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'andrea@resmed.com.
- Root cause
- Use error
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 1519 units
- Distribution
- Worldwide distribution. US nationwide, Uruguay and Canada.
- Date initiated
- 2015-05-05
- Date posted
- 2015-06-10
- Date terminated
- 2016-04-07
- Location
- NSW, Australia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASTRAL VENTILATOR (K133868) | Resmed, Ltd. | 2014-06-04 |