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Astral 100 and Astral 150 ventilators recallZ-0111-2024 · ResMed Ltd. · initiated Sep 13, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ResMed Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

On 9/13/23 Field Safety Notices were emailed to distributors, institutions, medical facilities. The notices states to immediately provide a copy of the notice and the patient/carer letter to all patients, carers, and relevant healthcare professionals. The notices states: Continue using your Astral ventilator, provided you continue to follow the instructions detailed in the Astral User Guide. -Connect the ventilator to mains power whenever possible. In the event of battery failure, connect to mains power immediately to resume ventilation. - Internal battery is not intended to serve as a primary power source. It should only be used when other sources are not available or briefly when necessary. -External power source should always be available for ventilator-dependent patients. -External power source should be in use in mobile situations, including when mains power is unavailable or disrupted. Do not rely solely on the internal battery for mobile use. - Ensure the external battery is sufficiently charged before using in mobile situations. - For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device. - Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers. Consistently follow the 2-year ventilator preventative maintenance schedule to help detect and replace circuit boards with degraded supercapacitors. A second phase will be communicated to customers. Follow the updated service process detailed in Tech Note 1063673; not sent to patients/carers. Complete/return the acknowledgment form: [email protected]. Questions - contact your local ResMed contact. On 3/18/24, a second Field Safety Notice was sent requesting that devices be returned to a Service Center as soon as possible, but no later than the end of March 2025 to receive software update R6.2 (SX544-0603).

Recall details

Recall number
Z-0111-2024
Status
Open, Classified
Initiated by the company
Sep 13, 2023
Posted by the FDA
Oct 23, 2023
Recalling firm
ResMed Ltd.
Quantity
55,279 (US 16,634; OUS 38,645)
Product code
CBK
FDA submissions
K172875
Distribution
Worldwide - US Nationwide distribution including in the states of CA, NJ, VA, IN, MI, WV, NY, WI, ND, IL, NC, FL, CO, TX, AL, LA, MD, OR, AZ, MN, WA, PA, SC, MA, ID, GA, SD, TN, NH, OH, MS, CT, IA, KY, UT, NE, MO, NV, AR, WY, RI, KS, VT, ME, OK, PR, MO, DC and the countries of Taiwan, Israel, Spain, Slovenia, Belgium, Italy, Australia, Guatemala, Argentina, Uruguay, Chile, France, Martinique, Germany, French Polynesia, Korea, Egypt, Colombia, United Kingdom, Jersey, Ecuador, Reunion, Greece, Brazil, Cyprus, Saudi Arabia, Czech Republic, Thailand, New Caledonia, Mauritius, Canada, Vietnam, Indonesia, Pakistan, Japan, Guadeloupe, South Africa, Iran, Hungary, Tunisia, Nepal, Iceland, New Zealand, Austria, Portugal, Malaysia, Norway, Netherlands, Sweden, Lebanon, Finland, Singapore, United Arab Emirates, Peru, Oman, Philippines, Bahrain, French Guiana, Mexico, Sri Lanka, India, Kuwait, Bangladesh, Kenya, Myanmar, Turkey, Bulgaria, Croatia, Hong Kong, Saint Martin, Qatar, Jordan, Romania, Maldives, Denmark, Poland.

Product description

Astral 100 and Astral 150 ventilators

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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