Terminated

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.

FDA Recall Z-0746-2016 · Posted 2016-02-03

Recalling FirmResmed Corporation

Recall StatusTerminated

Product CodeCBK

Date Initiated2016-01-13

Date Terminated2016-04-22

Product Quantity14,736

Reason for Recall

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

Firm Action

ResMed sent an Urgent Safety Alert dated January 13, 2016, to all affected customers. The Alert identified the product, the problem, and the action to be taken by the customer. The notification letter provided the following instructions to distributors Field devices can be upgraded using ResMed Service Software or at an authorized ResMed Service Center. Contact Astral Support for further details. The SR2 software update will be available free of charge and should be implemented for all devices within the two-year service cycle or before at the customers preference. To acknowledge receipt of this Astral Safety Alert, submit this form. For any questions call Astral Support: 855-245-4640

Root Cause

Software design

Distribution Pattern

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.

Official Source

View FDA Recall →

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