Z-1801-2020Class II

Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional...

Name: Z-1801-2020 Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional...
Creator: Philips North America, LLC
Published: 2020-03-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-03-05 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the... on 2020-03-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1801-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-05
Posted: 2020-04-24
Terminated: 2022-09-09
Recalling firm: Philips North America LLC
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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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..
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1801-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1801-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-24

Product code JAA

K181830Class IIAzurion R2.0Philips Medical Systems Nederland B.V. / cleared 2018-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)