Philips Respironics Recall Information
Philips Clincial Information - Sleep and Respiratory Care Update
FDA Safety Communication
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.
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:
The first step is to register your device so Philips can facilitate sending a replacement.
- To register your device, please 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.