Home / Recalls / Philips North America, LLC / Z-1801-2020

Z-1801-2020 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

FDA device recall Z-1801-2020 was initiated by Philips North America, LLC on March 5, 2020 and is designated Class II. 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.. The recall status is terminated (terminated September 9, 2022). Affected quantity: 162 units.

Recall Details

Product Type
Devices
Report Date
May 6, 2020
Initiation Date
March 5, 2020
Termination Date
September 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
162 units

Product Description

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.

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..

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.

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

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FDA data resources