Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Phillips Azurion 7 M20

  • 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 Phillips Azurion 7 M20 see related information
Date Initiated by Firm March 05, 2020
Create Date April 24, 2020
Recall Status1 Terminated 3 on September 09, 2022
Recall Number Z-1801-2020
Recall Event ID 85205
510(K)Number K181830  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079

Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
Code Information Serial Numbers:  709, 710, 711, 713, 716, 715, 439, 526, 637, 653, 684, 621, 497, 792, 595, 674, 737, 628, 429, 605, 895, 540, 769, 668, 697, 758, 633, 520, 738, 691, 813, 428, 590, 706, 611, 655, 804, 663, 588, 877, 854, 654, 488, 836, 689, 717, 790, 629, 598, 736, 810, 841, 946, 795, 673, 776, 645, 646, 703, 608, 805, 746, 262, 730, 753, 878, 755, 837, 618, 594, 714, 543, 751, 263, 766, 817, 741, 534, 535, 536, 466  System Equipment Numbers: 74620447, 74620437, 74613625, 74613538, 74620341, 77839007, 73340583, 73326701, 77646555, 77559977, 77970948, 77427180, 72722066, 79132604, 72273457, 76100048, 77970800, 74620302, 72805859, 77228623, 80018072, 74611961, 77647014, 75486269, 78248928, 75486357, 76888124, 75581571, 78243622, 75423992, 77971015, 74817549, 76890243, 74352012, 77260210, 77213972, 78993356, 77347585, 75532686, 79152378, 79109118, 75533239, 74536213, 79152254, 77838972, 78150020, 78696158, 77559984, 76481840, 75848181, 79112403, 77905831, 80171865, 79042710, 77697096, 77213970, 74778339, 74778897, 73051857, 73717291, 78132484, 75305793, 72312081, 76890941, 76888973, 78365267, 76888978, 79464469, 72323525, 72323935, 74169336, 74620425, 76891009, 72417922, 79035318, 79035262, 78367631, 74584486, 74584491, 75615010, 75470091 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Mr. Roland Telson
978-659-7275
Manufacturer Reason
for Recall		 No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..
FDA Determined
Cause 2		 Component design/selection
Action The firm, Philips, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter to the US and an "URGENT-Field Safety Notice" letter to the OUS (foreign countries) dated 2/26/20 on 3/5/2020 to all consignees by certified mail. These letters to all users explained that no torque was specified for the screws that connect the gearbox and the mounting flange within the C-arm roll motor assembly. A low torque could cause stress on the system and result in a loosening of the screws. If this occurs, the C-arm could rotate freely and uncontrolled movement could cause collision and/or entrapment. Philips asked that all users of the system be informed of the issues and to place a copy of the Field Safety Notice in the Instructions for Use for the system. Philips will exchange the roll motor in all affected systems free of charge, starting in March 2020. A local Philips representative will contact each consignee to schedule the roll motor replacement. If you need any further information or support concerning this issue, please contact your local Philips representative. Technical Support Line: 1-800-722-9377.
Quantity in Commerce 162 units
Distribution Worldwide distribution: US (nationwide) including the following states: Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia, Wisconsin. And the following Countries of: Australia, Azerbaijan, Chile, Croatia, Czechoslovakia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Korea South, Lebanon, Mexico, Netherlands, Norway, Pakistan, Poland, Russian Federate, Senegal, Spain, South Africa, Sweden, Switzerland, Taiwan, and Uruguay.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JAA and Original Applicant = Philips Medical Systems Nederland BV
-
-