Recall Z-0746-2016— Resmed Corporation

Name: FDA recall Z-0746-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-13

Class II · Terminated

Class II FDA medical device recall by Resmed Corporation, initiated 2016-01-13, terminated 2016-04-22. It names one FDA 510(k) clearance: K133868. Product: Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.. Reason: Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue..

Recalling firm: Resmed Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-01-13
Terminated: 2016-04-22
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K133868 — ASTRAL VENTILATORResmed, Ltd.·cleared 2014-06-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.

Reason for recall

Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.

Data sourced from openFDA. This site is unofficial and independent of the FDA.