Philips Sleep & Respiratory Care Products Recall

TRINIDAD NAVARRO COMMISSIONER [LOGO] STATE OF DELAWARE DEPARTMENT OF INSURANCE # DOMESTIC & FOREIGN BULLETIN NO. 126 TO: ALL DOMESTIC AND FOREIGN INSURERS WRITING HEALTH INSURANCE IN DELAWARE RE: PHILIPS SLEEP & RESPIRATORY CARE PRODUCTS RECALL DATED: August 2, 2021 The purpose of this bulletin is to: - Inform health insurance carriers of a recall of certain Philips sleep & respiratory care products; and - Strongly encourage carriers to work closely with their insureds concerning coverage for replacement machines. On June 14, 2021, Philips issued a recall notification for specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (Bi-Level PAP) devices, and Mechanical Ventilators, due to potential adverse health risks related to exposure to degraded sound abatement foam used in these devises. The affected devises are tabulated on the next page of this bulletin. The Department is aware that most health insurance plans do not cover the cost of replacement of devises that are less than five years old. However, the Department strongly encourages health insurance carriers to make an exception to cover the replacement of these life-saving devises. Philips advises that the possible health risks if recalled devises remain in use include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. For more information, visit the Philips website at Philips.com/SRC-update. Questions concerning this Bulletin should be emailed to: consumer@delaware.gov. This Bulletin shall be effective immediately and shall remain in effect unless withdrawn or superseded by subsequent law, regulations, or bulletin. Trinidad Navarro Trinidad Navarro Delaware Insurance Commissioner NOTE: This Bulletin is intended solely for informational purposes. It is not intended to set forth legal rights, duties, or privileges, nor is it intended to provide legal advice. Readers should consult applicable statutes and rules and contact the Delaware Department of Insurance if additional information is needed. ◆ INSURANCE.DELAWARE.GOV ◆ 1351 W. NORTH ST., SUITE 101, DOVER, DELAWARE 19904-2465 (302) 674-7300 DOVER ◆ (302) 259-7554 GEORGETOWN ◆ (302) 577-5280 WILMINGTON # TABLE OF DEVISES PER PHILIPS' FAQ SHEET | Products Affected by Recall | | Products NOT affected by Recall | | --- | --- | --- | | **CPAP and BiLevel PAP Devices** **(All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers)** | | Trilogy Evo Trilogy Evo OBM Trilogy EV300 Trilogy 202 A-Series Pro and EFL M-Series DreamStation 2 Omnilab (original based on Harmony 2) Dorma 100, Dorma 200, & REMStar SE V60 Ventilator V60 Plus Ventilator V680 Ventilator All oxygen concentrators, respiratory drug delivery products, airway clearance products. | | 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 | | | **Mechanical Ventilators** **(All Affected Devices Manufactured Before 26 April 2021, All Device 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 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US) | | 2