After a massive recall caused sleepless nights for millions of sleep apnea patients globally, some users are concerned the company behind the recall, Philips Respironics, is not keeping its promises.
Philips Respironics announced last year a voluntary recall of some of the most popular sleep-aid devices prescribed by doctors for apnea patients – several different CPAP, Bi-PAP and ventilator devices – after it was discovered a noise-canceling foam inside could disintegrate and be inhaled by the user.
The Food and Drug Administration warned that the foam could be toxic or carcinogenic.
The news came as a surprise to Jackie Wright of North Texas.
"I've been using a CPAP machine for well over, I'd say, at least 15 years," Wright said. "The machine has helped me tremendously."
But Wright said she only learned about the recall and risks inside her device by chance after a doctor’s visit when it came up unexpectedly.
"I was at my doctors and they said, 'Oh, your machine’s on recall.' And I said, 'I didn't know anything about it.'"
Given the scale of the recall, which impacted more than 15 million devices, Philips Respironics said it would take up to a year to repair or replace every device.
The announcement left patients like Wright facing a false choice: Use a risky appliance or risk not waking up at all given their apnea disorder.
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Wright waited a year and then received more bad news.
"Now [Philips Respironics] is saying, 'Sorry, it's too old. … You are only eligible for $50.'"
Even though Wright’s System One CPAP device was included in the original recall list, Philips said older devices are "past their warranty and useful life," meaning those older devices are not eligible for new parts.
The company is offering those patients two options: return the old machine for a $50 check or see a doctor for a new prescription in order to get a newer model.
Philips Respironics tells NBC 5 Responds, in part, "One of the more complex aspects of the recall has been creating remediation options for older devices … such as the System One."
Since the devices have been discontinued, it doesn’t have a repair option.
After NBC 5 Responds contacted Philips about Wright’s situation, she was able to get a new prescription and her replacement claim was expedited.
Wright now has a new CPAP device and she hopes what happened to her will be part of a new pattern for the company.
“They should take care of everybody's machines,” Wright said.
Philips Respironics said it expects to repair or replace the vast majority of devices impacted by the recall by the end of this year.
To learn how to register your device with Philips Respironics, click here.
Below is a complete list of the Philips Respironics machines that are impacted, according to the FDA:
CPAP and BiPAP Devices
| Device Type | Model Name and Number (All Serial Numbers) |
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use | E30 (Emergency Use Authorization) |
| Continuous Ventilator, Non-life Supporting | DreamStation ASV, DreamStation ST - AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ |
| Noncontinuous Ventilator | SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto |
Ventilators
| Device Type | Model Name and Number (All Serial Numbers) |
| Continuous Ventilator | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent |
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use | A-Series BiPAP Hybrid A30 (not marketed in the US), A-Series BiPAP V30 Auto |
| Continuous Ventilator, Non-life Supporting | A-Series BiPAP A40, A-Series BiPAP A30 |
