—#180275

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.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181830
Affected lot / code info: 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

Why it was recalled

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..

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-03-05
Terminated: 2022-09-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180275. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.