Recall Z-1322-2023 ยท BZD Ventilator, Non-Continuous (Respirator)
Philips Respironics, Inc.
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.
| Date | Apr 6, 2023 (initiated Feb 10, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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. E |
| Quantity | 1233 devices |
| Distribution | US Nationwide. France, Reunion. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131982 | REMSTAR AUTO A-FLEX HT Respironics, Inc., Oct 18, 2013 |