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FDA Medical Device Recall Notification for ResMed Stellar Ventilators

Date: 03/05/20

Sunrise, Florida

As part of our commitment to quality care and the safety of our members, Sunshine Health would like to inform you of an FDA Class I Medical Device Recall for ResMed Stellar Ventilators for Stellar 100 and 150 non-invasive and invasive ventilators.

Sunshine Health strongly discourages the utilization of these devices and cautions all providers not to use them, effective immediately.

These Stellar 100 and 150 non-invasive and invasive devices are used in hospitals, homes, or for mobile use with wheelchairs. The sound alarm in these devices may fail to work and may cause serious injuries or death.

You can find additional information by visiting the FDA website.

For further assistance, contact Sunshine Health Provider Services at 1-844-477-8313.