Reported Apr 12, 2023 · Ongoing
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F,…
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
- 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.
- Lot codes and dates
- GTIN/HIBC
HIBCUCDSX500S11GTINUDSX500S11FHIBCUDSX700S11GTINUDSX700S11FGTINUFRX500S14
- Serial Numbers
1,233 of 1,233 codes
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
- GTIN/HIBC
- Amount recalled
- 1233 devices
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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