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U.S. Department of Health and Human Services

Class 1 Device Recall DreamStation1 (Uno Remediated Device)

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  Class 1 Device Recall DreamStation1 (Uno Remediated Device) see related information
Date Initiated by Firm February 10, 2023
Date Posted April 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-1322-2023
Recall Event ID 91837
510(K)Number K131982  
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
Product Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
Code Information GTIN/HIBC: HIBCUCDSX500S11, GTINUDSX500S11F, HIBCUDSX700S11, GTINUDSX700S11F, GTINUFRX500S14; Serial Numbers: J24421197E010, J201506009824, J20558590552C, J21032984C317, J21209966AF9A, J217958772FC0, J232909614499, J232986192AC6, J239466352C09, J26991149FC9E, J285824687E46, J169457430155, J18040704DF8F, J181773679463, J18342322DF63, J185233902700, J18531602D885, J185960074278, J186478392B1E, J186751020701, J187324621476, J188283663434, J18833555314F, J188893710940, J188945627411, J18897822C9C3, J1891938599E3, J18951421667A, J189800136CAE, J19017668F54F, J190409177B02, J1906385333DF, J190720281139, J19096115A93C, J19100094327C, J19295259C6CF, J193008337527, J19336718E4D5, J193380465154, J1934276067A5, J19397348A91F, J193977064460, J194128342F7B, J19434423BAAD, J19438211F23A, J194617995638, J19560765070C, J19572114BF66, J19599936C8AB, J196015973930, J196616324711, J196622212AFE, J19663444E3E1, J19681407EED4, J196887815325, J19693965545B, J197027417820, J19740100CC76, 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Recalling Firm/
Manufacturer		 Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Philips Customer Service
800-722-9377
Manufacturer Reason
for Recall		 A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action An Important Product Notice was sent to customers on 2/10/23. For DMEs: 1. Should the prescription settings of the device be affected by this issue, the patient may find the device provides different pressure and comfort settings than the patient is accustomed to. 2. The DreamStation is designed to provide CPAP, CPAP-Check, Auto CPAP, Bi-Level and Auto Bi-Level therapy. Affected product can be determined by locating the serial number of the replacement device and verifying it against the serial number noted in this letter below. 3. Affected device serial number(s) are noted in the letter. Enclosed is the letter that should be provided to your affected patients. Replacement product will be provided to you for exchange of affected devices. 4. If you need any further information or support concerning this issue, please contact 1-800-345-6443, prompts 4, 5 or email at respironics.clinical@philips.com. For Patients: Affected product can be determined by locating the serial number of the replacement device and verifying it against the serial number noted in this letter below. The device may continue to be used until the replacement device is received. The affected device serial number is noted in the letter. Philips will attempt to contact the patient via phone call to set up replacement and return of the device affected by this issue. No further action is necessary by the patient. Philips will attempt to contact the patient via phone call to set up replacement and return of the device affected by this issue. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-(877)-387-3311 or email at patientsupport@philips.com.
Quantity in Commerce 1233 devices
Distribution US Nationwide. France, Reunion.
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 = RESPIRONICS, INC.
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