Reported May 6, 2020 · Terminated

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

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • 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 areasvascular, non-vascular, cardiovascular and neuro procedures
Lot codes and dates
  • Serial Numbers

    81 of 81 codes

    • 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
  • System Equipment Numbers

    81 of 81 codes

    • 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
Amount recalled
162 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

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..

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 9, 2022 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.