Philips North America, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Philips North America, LLC is recalling Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, inter due to 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 scr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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..
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026