Reported Aug 14, 2019 · Terminated
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12,…
Philips North America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips Azurion systems with software version R1.2 -Interventional
- Fluoroscopic X-ray system as follows
Azurion 3 M12Azurion 3 M15Azurion 7 B12Azurion 7 B20Azurion 7 M12
- Azurion 7 M20 Models
722063722064722067722068722078722079
- Product UsageThe Azurion series (within the limits of the used Operating Room
- table) are intended for use to performImage guidance in diagnostic, interventional and minimally invasive surgery procedures for the
- following clinical application areasvascular, non-vascular, cardiovascular and neuro procedures Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures
- AdditionallyThe Azurion series can be used in a hybrid Operating Room. The Azurion series contain a number of features to support a flexible and patient centric procedural workflow
- Lot codes and dates
- Software version R1.2
- Amount recalled
- 834
Where it was sold
- Nationwide
Why it was recalled
The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
This product could cause temporary or reversible health problems — stop using it.
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