Resmed Corporation recalls Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for

Recalled February 10, 2016 · FDA recall Z-0746-2016 · Resmed

Hazard

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

Units

14,736

Sold at

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.

Description

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

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.

Manufacturer(s)

Resmed Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →