PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provi
Summary
The FDA issued a Class II for PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1 by Fisher & Paykel Healthcare, Ltd.. Reason: 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.
Details
Source
Device Recall
External ID
Z-3262-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
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.
Lot/Code Info: Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers:
Quantity Affected: 944 units
Reason for Recall
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-07
Company
Auckland
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fisher & Paykel Healthcare, Ltd. has 18 FDA actions in our database, including 3 recalls and 15 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fisher & Paykel Healthcare, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fisher & Paykel Healthcare, Ltd. have FDA actions?
Fisher & Paykel Healthcare, Ltd. has 18 FDA actions in our database, including 3 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3262-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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