We know how important it is to feel confident that your therapy device is safe to use.As we continue to work through the voluntary recall, we assure you that we are fully committed to supporting all patients and will continue to partner with clinicians and business customers to complete recall efforts. The latest results of the testing and analysis we have done over the past 18 months can be found here.
Since the recall, we’ve carried out a test and research program to learn more about the polyester-based polyurethane (PE-PUR) sound abatement foam, working with independent laboratories and third party experts and physicians. It is important that patients feel confident using their devices. With devices ready for patients, we are asking customers and clinicians to help get these devices to those who need them by reminding patients that they may need to take specific action in the Patient Portal to receive their replacement device. We are committed to completing the remediation of all registered devices and have substantially increased the production of replacement devices.
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