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Class 2 Device Recall ARTIS ONE |
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Date Initiated by Firm |
March 21, 2023 |
Date Posted |
April 27, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1469-2023 |
Recall Event ID |
92118 |
510(K)Number |
K133580
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600 |
Code Information |
UDI-DI: 04056869009964
US Serial Numbers:
82587
82570
82577
82562
OUS Serial Numbers;
82601
82629
82663
82695
82432
82542
82619
82631
82433
82574
82606
82610
82655
82675
82676
82700
82705
82706
82326
82327
82438
82454
82477
82484
82494
82500
82502
82506
82508
82512
82515
82516
82517
82519
82520
82525
82526
82529
82530
82531
82533
82536
82537
82539
82540
82549
82561
82568
82576
82581
82582
82585
82586
82593
82594
82599
82607
82608
82609
82616
82617
82618
82621
82622
82625
82626
82628
82639
82642
82643
82644
82646
82647
82649
82650
82651
82661
82662
82673
82685
82687
82689
82690
82693
82698
82699
82702
82703
82707
82349
82532
82546
82589
82592
82603
82634
82635
82652
82679
82548
82704
82583
82407
82555
82495
82667
82543
82666
82528
82545
82552
82668
82671
82523
82659
82565
82447
82482
82572
82638
82640
82701
82403
82467
82498
82535
82580
82678
82680
82600
82597
82237
82563
82225
82692
82567
82554
82573
82579
82553
82670
|
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact |
SAME 610-219-4834
|
Manufacturer Reason for Recall |
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
|
FDA Determined Cause 2 |
Device Design |
Action |
Siemens issued a Urgent Medical Device Correction letter AX065/22/S on 3/21/23.
Letter states reason for recall, health risk and action to take:
has been performed. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient.
Siemens will correct the hardware error via Update Instruction AX061/22/S. This measure will replace the current hybrid cable with a design improvement to enhance stability and quality of the signal transmission. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. |
Quantity in Commerce |
4 units US |
Distribution |
Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of
Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia,
Iraq, Japan, Malaysia, Morocco, Nepal, Nigeria, Poland, Russia, Rwanda, Serbia, Slovenia, South Africa, Spain, Sudan, Syria, Taiwan, Thailand, Uganda, Ukraine, United Kingdom, Uzbekistan, Vietnam. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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