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The FDA has mandated that Philips must tell customers, including suppliers and patients, about its ventilator and sleep apnea machines recall. The FDA considers Philips’ previous efforts at notifying customers to be insufficient, and therefore wishes to eliminate the risk of harm the recalled items pose.
Philips began to recall specific ventilator and sleep apnea machines 9 months ago. However, despite the FDA labeling this as a Class I event, there seems to be a large portion of customers who have heard nothing about the recall.
In addition, the FDA is concerned that Philips is not providing consumers with enough information about how to return the potentially defective items and obtain replacements.
Better Communication from Philips Required
Medical equipment suppliers as well as customers who are not aware of this recall and/or have not obtained enough information about how to exchange their recalled devices are understandably frustrated.
The FDA has stepped in to ensure Philips Respironics will improve recall communication and include information about the risk of the foam which is part of the recalled products. There are many consumers who rely on these medical devices on a daily basis.
Products Were Recalled in June 2021
This recall dates back to last summer when the company publicly shared information about safety issues with some of their devices. The recall concerns the foam inside machines degrading and breaking down. The consumer then has the risk of ingesting or inhaling these foam particles. Over 5 million devices are affected by this product recall.
Once it has broken down, the foam poses serious risks. These include life-threatening injuries, as well as those which can require medical intervention or cause permanent impairment.
Philips has been instructed by the FDA to improve their efforts at notifying users, distributors, healthcare providers, retailers, and durable medical equipment suppliers about the health risks the foam inside the recalled products entail.
Philips has 45 Days to Comply
The FDA has specified that Philips must include ‘prominently displayed information’ on their website regarding this recall as well as the risk of using ozone products when cleaning the devices, as this is one of the factors causing the foam to break down.
Another order from the FDA mandates Philips to give a description of the foam testing carried out on these machines. The vague information on Philips’ website to date does not provide sufficient information for healthcare providers to make informed decisions about the foam risks, and the FDA has given Philips 45 days to make these changes.
A Statement from Philips
A Philips spokesperson says they are doing and will continue to do all they can to support customers, medical professionals and patients, and be transparent about the recall reasons and simplify the recall process.
According to a press release from last Thursday, Philips has successfully reached more than half of their base in the United States, registering 2.6 million of these devices.
Over 650,000 replacements have already been shipped to US customers and the replacement program is due to be completed by the end of this year. The company did not specify how many remaining customers they still have to reach.
A Potentially Expensive Mistake
Philips could be hundreds of millions of dollars out of pocket because of this and their rival ResMed could get a firmer grip on this market. Philips has set aside some $825 million to fund this recall. As they face lawsuits both in and outside of the United States, Philips could face a greater financial impact however.
There are around 100 class-action lawsuits at present, alleging medical monitoring and economic losses from locations such as Canada, Australia and Israel. Although it is likely Philips will have to spend millions on this recall and corresponding class-action lawsuits, uncertainty concerning their potential obligations cannot be reliably estimated at this time.