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Astral
RESMED PTY LTD · Model 19948 · UDI-DI 00619498199488
7
510(k) clearances
6,912
Adverse events (92 deaths)
16
Recalls
29
Facilities
Description
Software Upgrade Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-25 | Ventec Life Systems, Inc. | Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing |
| 2024-07-25 | Breas Medical, Inc. | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. |
| 2024-07-16 | Philips Respironics, Inc. | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier reca |
| 2024-07-16 | Philips Respironics, Inc. | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier reca |
| 2023-10-13 | Breas Medical, Inc. | Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of |
| 2022-06-02 | Breas Medical, Inc. | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT f |
| 2021-07-26 | Philips Respironics, Inc. | Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the se |
| 2021-07-26 | Philips Respironics, Inc. | Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the se |
| 2021-07-26 | Philips Respironics, Inc. | Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the se |
| 2020-01-28 | Breas Medical, Inc. | The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.