Chat with us below Home Medical Equipment Home Access SNF Solutions Patient Tools Contact Information Philips Respironics Recall Information Patient Instructions The first step is to register your device so Philips can facilitate sending a replacement. To register your device, please call 1-877-907-7508 or visit www.philips.com/src-update Follow the link on the right side of the page that says “Begin Registration Process” You will need to enter your device serial number. The serial number is located on the bottom of the CPAP devices, starts with the letter J. Please remember to empty your humidifier before turning over your device to read the number. If you have already registered your device, please call 1-800-644-3324 for replacement status. Philips Clincial Information - Sleep and Respiratory Care Update Updated July 8, 2021 Sleep and Respiratory Care Clinical Information FDA Safety Communication Updated June 30, 2021 The U.S. Food and Drug Administration (FDA) has just issued a Safety Communication regarding Philips’ recent recall of certain respiratory devices. The FDA communication summarizes major issues and considerations related to the recall, and encourages patients using BiPAP and CPAP machines to discuss treatment options and alternatives with their healthcare providers, including “Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.” The FDA also notes that they are working with Philips to evaluate the issue, the scope of the recall, and appropriate mitigation strategies. The Agency is also analyzing medical device reports related to the affected devices over the period of 2009-2021 for reports that could be related to this issue. The communication also urges patients to register their devices to Philips’ website and also includes a link to the Medwatch Reporting Form where individuals can report problems with their devices directly to the FDA. Suppliers are encouraged to share these links with their patients. By registering their devices with Philips, patients will help provide useful data on the total number of devices affected. The registration link can be found under the "Patients, Users, and Caregivers" heading on Philips recall website. Here is a direct link. FDA MedWatch Voluntary Reporting Form. See FDA’s complete Safety Communication here. Philips Respironics Recall Notification Updated June 23, 2021 Philips Respironics, the manufacturer of PAP or Trilogy ventilation devices has announced a voluntary recall of their equipment due to possible health risks. Not all devices are affected by this recall, please visit www.philips.com/src-update for: Recall notification List of affected devices Recommendations from Philips Respironics It is our understanding that Philips Respironics, in collaboration with a third- party processor is formulating a plan to repair or replace your unit. Unfortunately, Health System Services will not be allowed to repair or replace your unit directly. We apologize, but this is all the information we have at this time. This webpage will be updated as we receive more information from Philips. Please follow patient instructions and see FAQ below: FAQ My machine is on the impacted devices list, what should I do? Expand Should I continue using my device? Expand Is this causing my current health problem? Expand When can you help me? Expand What is HSS doing to fix the problem? Expand I am a new CPAP patient. How are you prioritizing set up appointments? Expand Are ResMed devices subject to this recall? Expand NEW MACHINE/REPAIRS Why can't you give me a new machine? Expand Can I buy a different machine? Expand Will my insurance pay for a replacement now? Expand How long until I get a replacement machine? Expand Can I take the foam out myself? Expand COMPLIANCE AND ALTERNATIVES TO THERAPY I stopped using my PAP machine and now am exhausted, what can I do? Expand I am employed as a driver and need to report compliance, what should I do? Expand Can I still use my SoClean/Ozone cleaning device? Expand We are here for you. Corporate Headquarters: 6867 Williams Road Niagara Falls, NY 14304 Toll Free: 1-888-638-4477 Local: 1-716-283-4879 Text: 716-304-2170 Fax: 716-283-1291 customerservice@healthsys.net Share your experience! © 2020 Health System Services Ltd. All Rights Reserved.