• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Philips

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Philipssee related information
Date Initiated by FirmJuly 16, 2019
Create DateAugust 06, 2019
Recall Status1 Terminated 3 on June 04, 2020
Recall NumberZ-2205-2019
Recall Event ID 83477
510(K)NumberK172822 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductPhilips 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
For Additional Information ContactSAME
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
ActionPhilips 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 Commerce834
DistributionUS 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 CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = OWB
-
-