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PT301US Airvo 3 Respiratory Support Device recallZ-3262-2024 · Fisher & Paykel Healthcare, Ltd. · initiated Aug 7, 2024

Class II Open, Classified All recalls posted in September 2024

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 Fisher & Paykel Healthcare, 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

Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.

FDA root cause category: Software change control

What the company is doing

On 08/13/2024, the firm sent an "Urgent: Medical Device Correction" Letter via email, phone, letter or face to face communication to inform customers that due to a software issue with the Airvo 3 (software version 1.5.1 or earlier) when the flow alignment alarm 3.2.2 occurs, Airvo 3 devices set up with high pressure oxygen the device will deliver room air only. Patients may experience oxygen desaturation that could lead to hypoxia. For Distributors - Actions required for affected products are: Step1-Identify affected products using Model Number reference (REF), Serial Number (SN) and Manufacturing Date (YYYY-MM-DD). If the device is still within your inventory, put the product in quarantine to prevent ongoing distribution until Fisher&Paykel (F&P) Healthcare has contacted you with next steps. Step2-Complete and return the attached response form Step3-Await instructions from Fisher&Paykel Healthcare For healthcare facilities: Until the software is updated, the Airvo 3 device can continue to be used by your customers. When using the device, all instructions, including warnings and cautions in the Airvo 3 User Manual must be followed, particularly those in Sections 1 and 2. If alarm 3.2.2 occurs, follow the onscreen instructions. For questions/assistance - contact F&P Field Action Team via email at [email protected] or directly at +1 (800) 446 3908 ext 5003 or +1 (949) 453 4000 ext 5003.

Recall details

Recall number
Z-3262-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 7, 2024
Posted by the FDA
Sep 25, 2024
Recalling firm
Fisher & Paykel Healthcare, Ltd.
Quantity
944 units
Product code
QAV
FDA submissions
K221338
Distribution
U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and WA. O.U.S.: Not provided

Product description

PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.

Code information (models, lots, serial numbers)

Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers:

Devices named in this recall

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

Sources and updates

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