IMPORTANT INFORMATION FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) REGARDING PHILIPS RESPIRONICS MEDICAL DEVICE RECALL NOTIFICATION

On June 30, 2021, the U.S. Food and Drug Administration (FDA) has just issued a Safety Communication regarding Phlips’s recent recall of certain respiratory devices. 

Please click here to read more about this Safety Communication from the FDA. 

IMPORTANT INFORMATION REGARDING PHILIPS RESPIRONICS MEDICAL DEVICE RECALL NOTIFICATION

On Monday, June 14, 2021, Philips issued a recall notification for many of its home respiratory equipment. Below is the list of all Philips respiratory devices that My Best Homecare carries that are affected by this recall.

Devices manufactured before April 26, 2021:

  • Trilogy 100 ventilator
  • Trilogy 200 ventilator
  • DreamStation ASV
  • DreamStation ST, AVAPS 
  • C-Series ASV  
  • C-Series S/T and AVAPS 
  • SystemOne 
  • DreamStation 
  • DreamStation Go 

More information about the recall can be found online at: 
www.philips.com/src-update

In essence, Philips is currently advising of the following immediate actions to be taken by You, the User. 

If you are using the Trilogy 100 or Trilogy 200 ventilator: 

  1. Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
  2. If your physician determines that you must continue using this device, use an in-line bacterial filter. Please contact My Best Homecare at 408-934-9617 if you do not know how to connect the bacteria filter to the Trilogy ventilator.
  3. Register your device on the recall website www.philips.com/src-updates
    1. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues.
    2. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
    3. Call 1-877-907-7508 if you cannot visit the website or do not have internet access.

If you are using any other devices listed above such as the DreamStation CPAP or BIPAP machine:

  1.  Discontinue use of your device and work with your physician or My Best Homecare to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in this recall. 
  2. Register your device on the recall website www.philips.com/src-updates
    1. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues.
    2. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
    3. Call 1-877-907-7508 if you cannot visit the website or do not have internet access.

We want you to know that My Best Homecare takes this recall very seriously. We have been in constant communication with Philips to seek out further guidance of a permanent corrective action to address the issues described in this Recall Notice. As of July 1, 2021, we still have not received any new information from Philips other than Philips does not have replacement ventilator or PAP devices for their distributors (us) or you at this time. 

We are also actively reaching out to other respiratory equipment manufacturers to explore other acquisition options. Unfortunately, due to the widespread recall affecting DME providers nationwide, the availability of new respiratory equipment is also very limited. 

For our patients that are currently using the Trilogy 100 and Trilogy 200 ventilator, we will continue to provide you with bacteria filters monthly to be used in-line with your ventilator as recommended by Philips. 

For our patients that are currently using any other Philips respiratory devices such as the DreamStation CPAP or BIPAP machine, stop using your device and consult with your physician as recommended by Philips. 

While the recall is initiated by Philips Respironics and is completely out of our control, we apologize for any inconvenience that this may cause. If you have any questions or concerns regarding this recall, we encourage you to contact Philips directly at 877-907-7508. Of course, you can always call us at 408-934-9617 at any time if you have any problems with your respiratory equipment. 

Best Regards,