Product Wiki · Recalls · U.S. FDA — Device Enforcement

Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are… — recall Z-0746-2016

U.S. FDA — Device Enforcement · United States · 2016-01-13 · Class II

As described by U.S. FDA — Device Enforcement: 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 pos

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0746-2016
Date of alert
2016-01-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Resmed Corporation
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR.
Reported risk: Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.