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ARTIS one with a hybrid cable- An angiography system… recallZ-1469-2023 · Siemens Medical Solutions USA, Inc · initiated Mar 21, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Examination room monitor connected with the hybrid cable may have a display issue and no image function is available

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1469-2023
Status
Open, Classified
Initiated by the company
Mar 21, 2023
Posted by the FDA
Apr 27, 2023
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
4 units US
Product code
OWB
FDA submissions
K133580
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.

Product description

ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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