Class 1 Device Recall DreamStation, DreamStation Go, Dorma 400, Dorma 500, and REMstar SE Auto

• Date Initiated by Firm: June 14, 2021
• Date Posted: July 13, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1974-2021
• Recall Event ID: 88058
• 510(K)Number: K122769 K131882 K131982 K130077 K091319 K113068
• Product Classification: Ventilator, non-continuous (respirator) - Product Code BZD
• Product: SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators; ; 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: AC250S AC550S AH250HS AH250S AH260HS AH260S AH260TS AH450HS AH450S AH550HS AH550S AH650HS AH650S AH750HS AH750S AU151HS AU151S AU251HS AU251S AU451HS AU451S AU551HS AU551S AU651HS AU651S AU751HS AU751S CA151HS CA151S CA251HS CA251S CA451HS CA451S CA551HS CA551S CA651HS CA651S CA751HS CA751S CN157HS CN157S CN257HS CN257S CN457HS CN457S CN557HS CN557S CN657HS CN657S CN757HS CN757S DE452HS DE452S DE552HS DE552S DE752HS DE752S DS150HS DS150S DS250HS DS250S DS450HS DS450S DS550HS DS550S DS650HS DS650S DS750HS DS750S FR355HS FR355S FR555HS FR555S HL454S HL554S IN151HS IN151S IN251HS IN251S IN451HS IN451S IN551HS IN551S IN651HS IN651S IN751HS IN751S JP256HS JP456HS JP456S JP556HS JP556S JP656HS JP756HS JP756S KP250HS KP250S KP450HS KP450S KP550HS KP550S KP750HS KP750S LA151HS LA151S LA251HS LA251S LA451HS LA451S LA551HS LA551S LA651HS LA651S LA751HS LA751S RIN551S RJP556S SH558HS SH558S UODS150S UODS250S UODS450S UODS550S UODS560S UODS650S UODS750S RTODS650HS 151BR LA151SBR 151P 157P 250P 251BR LA251SBR RBRLA251SBR 251P RBRLA251HS RBRLA251S 255P FR255HS FR255S 257P 355P 450P 451BR LA451SBR RBRLA451SBR 451P RIN451S RBRLA451HS RBRLA451S 452P UDE452S 454P 456P RJP456S 457P 550P 551BR LA551SBR RBRLA551SBR 551P RBRLA551HS RBRLA551S 552P UDE552S 554P 555P 556P 557P 651BR LA651SBR RBRLA651S RBRLA651SBR 651P 657P 750P 751BR LA751SBR RBRLA751SBR 751P RBRLA751HS RBRLA751S 752P 756P RJP756S 757P AU151H CA151 CA151H CA451HC CA451W CA551C CA551HC CN157 DS150 DS450C DS450D DS550C DS550HC KP450C KP450HC KP550C KP550HC RDS150S RDS250S RDS450S RDS520S RDS550HS RDS550S RDS650S RDS750HS RDS750S RIN751S UDS150S UDS250S UDS450S UDS520S UDS550S UDS650S UDS750S AHX200H11 AHX200H11C AHX200H11W AHX200S11 AHX200T11 AHX200T11C AHX200T11W AHX400H11 AHX400H11C AHX400H11W AHX400S11 AHX400T11 AHX400T11C AHX400T11W AHX500H11 AHX500H11C AHX500H11W AHX500S11 AHX500T11 AHX500T11C AHX500T11W AHX600H11 AHX600H11C AHX600H11W AHX600S11 AHX600T11 AHX600T11C AHX600T11W AHX700H11 AHX700H11C AHX700H11W AHX700S11 AHX700T11 AHX700T11C AHX700T11W ARX200H15 ARX200S15 ARX401H15 ARX401S15 ARX500H15 ARX500S15 ARX600H15 ARX600S15 ARX700H15 ARX700S15 AUX400H15 AUX400S15 AUX400T15 AUX400T15C AUX500H15 AUX500S15 AUX500T15 AUX500T15C AUX700H15 AUX700S15 AUX700T15 AUX700T15C BLX200H15 BLX200S15 BLX201S15 BLX201S15C BLX400H15 BLX400H15C BLX400S15 BLX400S15C BLX500H15 BLX500H15C BLX500H15MQ BLX500S15 BLX500S15C BLX600H15 BLX600S15 BLX700H15 BLX700S15 BRX200S18 BRX400S18 BRX404S18 BRX500S18 BRX504S18 BRX600S18 BRX700S18 CAX200H12 CAX200S12 CAX200T12 CAX400H12 CAX400H12C CAX400H12W CAX400S12 CAX400T12 CAX400T12C CAX400T12W CAX500H12 CAX500H12C CAX500H12W CAX500S12 CAX500S12C CAX500S12W CAX500T12 CAX500T12C CAX500T12W CAX501H12 CAX501H12C CAX501H12W CAX501T12 CAX501T12C CAX501T12W CAX600H12 CAX600H12C CAX600H12W CAX600S12 CAX600T12 CAX600T12C CAX600T12W CAX700H12 CAX700H12C CAX700H12W CAX700S12 CAX700S12C CAX700S12W CAX700T12 CAX700T12C CAX700T12W CNX200H17 CNX200T17 CNX400H17 CNX400T17 CNX500H17 CNX500T17 CNX600H17 CNX600T17 CNX700H17 CNX700T17 DEX400S13 DEX500S13 DEX700S13 DNX500H11C DNX500T11C DSX200H11 DSX200H11C DSX200H11W DSX200S11 DSX200S11C DSX200S11W DSX200T11 DSX200T11C DSX200T11W DSX400H11 DSX400H11C DSX400H11W DSX400S11 DSX400T11 DSX400T11C DSX400T11W DSX500H11 DSX500H11C DSX500H11CEP DSX500H11EP DSX500H11W DSX500H11WEP DSX500S11 DSX500S11C DSX500S11W DSX500T11 DSX500T11C DSX500T11CEP DSX500T11CMK DSX500T11EP DSX500T11W DSX500T11WEP DSX500T11WMK DSX600H11 DSX600H11C DSX600H11W DSX600S11 DSX600T11 DSX600T11C DSX600T11W DSX700H11 DSX700H11C DSX700H11CEP DSX700H11EP DSX700H11W DSX700H11WEP DSX700S11 DSX700S11C DSX700S11W DSX700T11 DSX700T11C DSX700T11CEP DSX700T11CMK DSX700T11EP DSX700T11W DSX700T11WEP DSX700T11WMK EEX200H15 EEX200S15 EEX400H15 EEX400S15 EEX401H15 EEX401S15 EEX500H15 EEX500S15 EEX600H15 EEX600S15 EEX700H15 EEX700S15 ESX200H15 ESX200S15 ESX201S15 ESX201S15C ESX400H15 ESX400S15 ESX401H15 ESX401H15C ESX401S15 ESX401S15C ESX401S15PR ESX500H15 ESX500H15C ESX500S15 ESX500S15C ESX600H15 ESX600S15 ESX700H15 ESX700S15 EUX200H15 EUX200S15 EUX400H15 EUX400S15 EUX401H15 EUX401S15 EUX500H15 EUX500S15 EUX600H15 EUX600S15 EUX700H15 EUX700S15 FRX400S14 FRX400S14W FRX401S14 FRX500S14 FRX500S14W FRX501H14W FRX501S14 FRX501S14W FRX700S14 FRX700S14W GBX200H15 GBX200S15 GBX400H15 GBX400S15 GBX401H15 GBX401S15 GBX500H15 GBX500S15 GBX600H15 GBX600S15 GBX700H15 GBX700S15 INX200H15 INX200S15 INX200T15 INX400H15 INX400S15 INX400T15 INX500H15 INX500S15 INX500T15 INX600H15 INX600S15 INX600T15 INX700H15 INX700S15 INX700T15 ITX200H15 ITX200S15 ITX400H15 ITX400H15W ITX400S15 ITX500H15 ITX500H15W ITX500S15 ITX600H15 ITX600S15 ITX700H15 ITX700S15 JPX400S16 JPX400S16C JPX500S16 JPX500S16C JPX501S16 JPX700S16 JPX700S16C KRX200H15 KRX200S15 KRX200T15 KRX400H15 KRX400S15 KRX400T15 KRX500H15 KRX500S15 KRX500T15 KRX600H15 KRX600S15 KRX600T15 KRX700H15 KRX700S15 KRX700T15 LAX200H15 LAX200S15 LAX200T15 LAX400H15 LAX400S15 LAX400T15 LAX500H15 LAX500S15 LAX500T15 LAX600H15 LAX600S15 LAX600T15 LAX700H15 LAX700S15 LAX700T15 NDX200H15 NDX200S15 NDX400H15 NDX400S15 NDX500H15 NDX500H15C NDX500S15 NDX500S15C NDX600H15 NDX600S15 NDX700H15 NDX700S15 PPX100S10 PTX500H15PR PTX500H15PRC PTX500H15PRW PWX401H15 PWX401S15 RDEX500S13 RDSX200S11 RDSX400S11 RDSX500S11 RDSX600S11 RDSX700S11 RGBX500H15 RGBX500S15 RGBX700S15 RJPX500S16 SHX500S11 TRX200H15 TRX200S15 TRX400H15 TRX400S15 TRX500H15 TRX500S15 TRX600H15 TRX600S15 TRX700H15 TRX700S15 UAX400S15 UAX500S15 UAX700S15 UCDSX400S11 UCDSX500S11 UCDSX700S11 UFRX500S14 VAX700H11 VAX700H11C VAX700T11 VAX700T11C ZAX200H15 ZAX200S15 ZAX400H15 ZAX400S15 ZAX500H15 ZAX500S15 ZAX600H15 ZAX600S15 ZAX700H15 ZAX700S15 DSX219S11 FRX500H14W INX219S15 RBRX700S18 RDEX400S13 RDEX700S13 RFRG503S14 RFRX1130S14 RFRX501S14 RFRX700S14 RJPX400S16 RJPX700S16 VAX500H11 VAX500H11C VAX500T11 VAX500T11C ARX200H15C ARX401H15C ARX500H15C ARX600S15C ARX700S15C LAX200H15C LAX400H15C LAX500H15C LAX600H15C LAX700H15C BRX200H18C BRX404H18C BRX504H18C BRX600H18C BRX700H18C UDSX200S11 UDSX400S11 UDSX500S11 UDSX600S11 UDSX700S11 ARG502S15 AUG400H15 AUG400S15 AUG500H15 AUG500S15 BLG500S15 BLG502S15 BRG502S18 CAG400H12 CAG400S12 CAG500H12 CAG500S12 CHG502S15 DEG500S13 DEG502S13 DSG400B11 DSG400H11 DSG400S11 DSG500H11 DSG500S11 ESG500S15 ESG502S15 EUG400S15 EUG500S15 EUG502S15 FRG501S14 FRG503S14 GBG500S15 GBG502S15 HKG502S15 IAG502S15 IDG502S15 ITG502S15 JPG500S16 LAG502S15 MYG502S15 NDG500S15 NDG502S15 PLG502S15 RDSG400S11 RDSG500S11 SAG502S15 SHG500S11 TRG502S15 TWG502S15 UDSG400S11 UDSG500S11 DEG400S13 RJPG500S16 DEV402 DEV402H AUV501 AUV501H BRV509 CAV501 CAV501H CNV507H DEV502 DEV502H INDV501 INDV501H INV501 INV501H LAV501 LAV501H TRV501 TRV501H CA521HS CA521NTS CA521S CA521TS DS520HS DS520S DS520TS CNV507HN1 RDEV402 RDEV502
• 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 = BZD and Original Applicant = ELECTRICAL GEODESICS, INC.; 510(K)s with Product Code = BZD and Original Applicant = RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP; 510(K)s with Product Code = BZD and Original Applicant = RESPIRONICS, INC.