# FDA recall Z-1322-2023

> **Philips Respironics, Inc.** · Class I · device recall initiated 2023-02-10.

## 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.

## 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.

## Distribution

US Nationwide. France, Reunion.

## Key facts

- **Recall number:** Z-1322-2023
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-10
- **Report date:** 2023-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Murrysville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2023

## Citation

> AI Analytics. FDA recall Z-1322-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1322-2023. Source: US FDA. Licensed CC0.

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