| Class 2 Device Recall Philips |  |
Date Initiated by Firm | July 16, 2019 |
Create Date | August 06, 2019 |
Recall Status1 |
Terminated 3 on June 04, 2020 |
Recall Number | Z-2205-2019 |
Recall Event ID |
83477 |
510(K)Number | K172822 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product | Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows:
Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20
Models: 722063, 722064, 722067, 722068, 722078, 722079.
Product Usage:
The Azurion series (within the limits of the used Operating 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 Operating Room. The Azurion series contain a number of features to support a flexible and patient centric procedural workflow. |
Code Information |
Software version R1.2 |
Recalling Firm/ Manufacturer |
Philips North America, LLC 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | SAME 978-659-3000 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Software design |
Action | Philips issued notification on July 16, 2019 advising users of the problem, health risk and action to take: If the start-up screen shows software version R1 .2, your system has the affected release and FC072200430 should be implemented on your system. If the start-up screen shows software version R1.2.1, your system has the latest system software release and is not affected by this issue.
Philips will also be contacting customers with affected systems directly.
Until Philips corrects your Philips Azurion system.
At least once every 50 days, briefly disconnect the Azurion system from the
mains power supply. Be aware that when an Uninterruptible Power Supply
(UPS) is installed, the room emergency power off switch should be used to
interrupt the mains power supply to the system. Note that this might also shut
down other devices or equipment in the room.
. Include this Field Safety Notice with the documentation of the system until
Philips implements this correction in your system.
Questions contact : your local Philips representative |
Quantity in Commerce | 834 |
Distribution | US Nationwide Distribution
Foreign:
Canada
Argentina
AUSTRALIA
Austria
Azerbaijan
Bahrain
Bangladesh
Belgium
Bosnia and Herzegovina
Brazil
Bulgaria
Chile
Colombia
CROATIA
Denmark
ECUADOR
Egypt
Finland
France
Germany
Greece
Hong Kong
India
Indonesia
Ireland
Israel
Italie
Italy
Japan
Jordan
Kazakhstan
Korea, Republic of
Latvia
Lebanon
Libya
Malaysia
Maldives
Mexico
Mongolia
Myanmar
Netherlands
New Zealand
Norway
Oman
Pakistan
Philippines
Polamnd
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Saudi Arabia
Serbia
Singapore
SLOVENIA
South Africa
Spain
Sri Lanka
Sweden
Switzerland
Thailand
Tunisia
Turkey
UNITED ARAB EMI
United Arab Emirates
United Kingdom
Uzbekistan
Viet Nam |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = OWB
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