OrbusNeich has a formal process for determining when Field Safety Corrective Actions (FSCA) are necessary. Occasionally, an FSCA may include urgent revisions to prescribed instructions for use. In these cases, OrbusNeich’s process requires the distribution of a Field Safety Notice to every Health Care Provider (HCP) that has received the affected product to inform them of the revised prescribed instructions for use. Field Safety Notices are generally distributed to HCP’s through local OrbusNeich Quality and Commercial organizations.