medical HIGH RISK Updated 2023-11-01

ResMed Ltd. recalls Astral 100 and Astral 150 ventilators

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Recalled Product

Astral 100 and Astral 150 ventilators

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Hazard / Issue

If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sound for less than 2 minutes or not at all

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All devices manufactured between 2013 and 2019. Device label lists the serial number, which includes the year of manufacture. For example, if the serial number is 22151234567, the 3rd and 4th digit are 15, meaning the device was manufactured in 2015. Astral 100, UDI: 00619498003259 Astral 150, UDI: 00619498003266

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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