The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidanc
Summary
The FDA issued a Class II for The Azurion series (within the limits of the used Operation Room table) are inte by Philips North America Llc. Reason: Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overhea.
Details
Source
Device Recall
External ID
Z-2476-2021
Action Date
2021-09-22
Status
Terminated
Category
device
Product Description
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
Lot/Code Info: Serial number: 921
Quantity Affected: 1 unit
Reason for Recall
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.
Distribution
US Nationwide distribution in the states of ID, MA, MI, TX, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-13
Company
Cambridge, MA
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 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
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 (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2476-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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