Class 1 Device Recall DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, CSeries ASV, CSeries S/T and AVAPS, Omni

• Date Initiated by Firm: June 14, 2021
• Date Posted: July 13, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1973-2021
• Recall Event ID: 88058
• 510(K)Number: K090248 K092818 K102465 K111378 K113053
• Product Classification: Ventilator, continuous, non-life-supporting - Product Code MNS
• Product: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.
• Code Information: All Serial Numbers Material Numbers: ARX900H15 ARX900S15 AUX900S15 AUX900T15 AUX900T15C BLX900H15 BLX900S15 BRX900S18 CAX900H12 CAX900S12 CAX900T12 CAX900T12C CAX900T12W DEX900H13 DEX900S13 DSX900H11 DSX900H11C DSX900H11W DSX900S11 DSX900T11 DSX900T11C DSX900T11W EEX900H15 EEX900S15 ESX900H15 ESX900S15 EUX900H15 EUX900H19 EUX900S15 EUX900S19 FRX900H14 FRX900S14 FRX900S14W GBX900H15 GBX900S15 INX900H19 INX900S19 INX900T19 ITX900H15 ITX900S15 JPX900S16 LAX900H19 LAX900S19 LAX900T19 NDX900H15 NDX900S15 PPX900S10 RGBX900S15 TRX900H15 TRX900S15 UAX900S15 UCDSX900S11 ZAX900H19 ZAX900S19 BRX900S18 RDEX900S13 RDEX900H13 RGBX900H15 TRX900H15 RDSX900S11 RFRX900S14 RJPX900S16 UDSX900S11 AUX1131H15 AUX1131H15C AUX1131H15W AUX1131S15 AUX1131S15C AUX1131S15W AUX1131T15 AUX1131T15C AUX1131T15W BLX1030H15 BLX1030S15 BLX1130H15 BLX1130S15 BRX1030S18 BRX1130S18 CAX1130H12 CAX1130H12C CAX1130H12W CAX1130S12 CAX1130S12C CAX1130S12W CAX1130T12 CAX1130T12C CAX1130T12W CNX1025H17 CNX1025S17 CNX1025T17 CNX1030H17 CNX1030S17 CNX1030T17 CNX1130H17 CNX1130S17 CNX1130T17 CNX1131H17 CNX1131S17 CNX1131T17 DEX1025H13 DEX1025S13 DEX1030H13 DEX1030S13 DEX1130H13 DEX1130S13 DSX1030H11 DSX1030H11C DSX1030H11W DSX1030S11 DSX1030S11C DSX1030S11W DSX1030T11 DSX1030T11C DSX1030T11W DSX1130H11 DSX1130H11C DSX1130H11W DSX1130S11 DSX1130S11C DSX1130S11W DSX1130T11 DSX1130T11C DSX1130T11W EEX1030H22 EEX1030S22 EEX1130H22 EEX1130S22 ESX1030H15 ESX1030H20 ESX1030S15 ESX1030S20 ESX1130H15 ESX1130S15 EUX1025H15 EUX1025H19 EUX1025S15 EUX1025S19 EUX1030H15 EUX1030H19 EUX1030S15 EUX1030S19 EUX1125H15 EUX1125H19 EUX1125S15 EUX1125S19 EUX1130H15 EUX1130H19 EUX1130S15 EUX1130S19 FRX1030H14 FRX1030S14 FRX1130H14 FRX1130S14 GBX1030H20 GBX1030S20 GBX1130H20 GBX1130S20 IN1161PLSA INX1025H19 INX1025H19C INX1025H19W INX1025S19 INX1025S19C INX1025S19W INX1025T19 INX1025T19C INX1025T19W INX1030H19 INX1030H19C INX1030H19W INX1030S19 INX1030S19C INX1030S19W INX1030T19 INX1030T19C INX1030T19W INX1125H19 INX1125H19C INX1125H19W INX1125S19 INX1125S19C INX1125S19W INX1125T19 INX1125T19C INX1125T19W INX1130H19 INX1130H19C INX1130H19W INX1130S19 INX1130S19C INX1130S19W INX1130T19 INX1130T19C INX1130T19W INX1131H19 INX1131H19C INX1131H19W INX1131S19 INX1131S19C INX1131S19W INX1131T19 INX1131T19C INX1131T19W ITX1025H21 ITX1025S21 ITX1030H20 ITX1030S20 ITX1125H21 ITX1125S21 ITX1130H21 ITX1130S21 LDX1130H23 LDX1130S23 MDX1130H25 MDX1130S25 NDX1030H15 NDX1030H20 NDX1030S15 NDX1030S20 NDX1130H15 NDX1130H20 NDX1130S15 NDX1130S20 PPX1000S10 PPX1100S10 PPX1300S10 RDEX1025S13 RDEX1130S13 RGBX1030S20 SAX1130H27 SAX1130S27 SHX1030S11 SPX1130H21 SPX1130S21 TRX1030H15 TRX1030H20 TRX1030S15 TRX1030S20 TRX1130H15 TRX1130S15 UAX1030H19 UAX1030S19 UAX1130H19 UAX1130S19 VTX1130H24 VTX1130S24 ZAX1030H19 ZAX1030S19 ZAX1130H19 ZAX1130S19 RDSX1130S11 RGBX1130S20 AU951HS AU951S CA951HS CA951S CN957HS CN957S DE952HS DE952S DS950HS DS950S FR955HS FR955S IN951HS IN951S JP956S LA951HS LA951S RJP956S UDS950S BR959S JP956HS RDS950S AH960HS AH960S AH960TS AH960XHS AH960XS AH960XTS AU961HS AU961S AU961TS AU961XHS AU961XS AU961XTS BR969S CA961HS CA961NTS CA961S CA961TS CA961XHS CA961XS CA961XTS CN967HS CN967S CN967TS DE962HS DE962S DE962TS DE962XS DS960HS DS960S DS960TS DS960XHS DS960XS DS960XTS FR965HS FR965S FR965TS IN961HS IN961S IN961TS JP966HS JP966S JP966TS LA961HS LA961S LA961TS RDS960S RIN961S UDS960S RIN951S S1106396 RDS960XS 1060485 1060486 1061418 1061419 1061420 1061421 1061422 1061423 1098346 AU1060486 AU1061419 AU1061421 AU1061423 CA1060486 CA1061419 CA1061421 CA1061423 CN1060486 CN1061419 CN1061421 CN1061423 FR1060486 FR1061419 FR1061421 FR1061423 JP1060486 JP1061419 JP1061421 JP1061423 R1061420 R1061421 U1060485 U1061420 CA1161HS R1060485 RDS1060S RDS1160S UDS1060S ZA1061X ZA1161X AH1060HS AH1060S AH1060TS AH1160HS AH1160S AH1160TS AR1061X AR1161X AU1161S AU1161X BR1169S CA1161X CA1161XTS CN1067HS CN1067S CN1067TS CN1167HS CN1167S CN1167TS DE1061S DS1060HS DS1060S DS1060TS DS1160HS DS1160S DS1160TS ES1061S ES1161X FI1061X FI1161X FR1065X FR1165X GB1061X GB1161X IN1061S IN1061X IN1161PL IN1161PLS IN1161PLV IN1161S IN1161X IN861S IT1061X IT1161S ND1061X ND1161X NO1061X NO1161X PT1061X PT1161X RIN1061X SE1061X SE1161X DE1161S 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111139 1111140 1111141 1111142 1111527 1111558 BR1111125 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111123 U1111124 1109581 1109582 1109583 U1111140 R1111138 R1111127
• Recalling Firm/ Manufacturer: Philips Respironics, Inc.; 1001 Murry Ridge Ln; Murrysville PA 15668-8517
• Manufacturer Reason for Recall: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Recall notification letters were sent to customers beginning on 6/14/21. Immediate Actions to be taken by You, the User: 1. Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. 2. Register your device on the recall website www.philips.com/src-updates Call 1-877-907-7508 if you cannot visit the website or do not have internet access. An updated URGENT: Medical Device Recall notification letter was issued on 11/16/21. Immediate Actions to be taken by You, the User: 1. Talk to your health care provider to decide on a suitable treatment for your condition, which may include: a. Stopping use of your device b. Continuing to use your affected device, if your hcpr determines that the benefits outweigh the risks identified in the recall notification. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea. 2. Follow the manufacturers instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Ozone cleaners may exacerbate the breakdown of the foam, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 3. Report any problems with a device through the FDA MedWatch Voluntary Reporting Form. 4. Register your device on the recall website www.philips.com/src-update with your device Serial Number. c. Call 1-877-907-7508 if you cannot visit the website or do not have internet access. Devices should be serviced only by qualified technicians. They do not include user serviceable parts. Attempts to remove the sound abatement foam may render the device permanently inoperative. Devices damaged due to attempts by the user to remove the sound abatement foam will not be able to be remediated.
• Quantity in Commerce: 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total
• Distribution: Global distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MNS; 510(K)s with Product Code = MNS; 510(K)s with Product Code = MNS