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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Siemens Medical Solutions USA, Inc
Reason for Recall:
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1469-2023

Related Recalls

MAMMOMAT Inspiration;

Siemens Medical Solutions USA

Class I - Dangerous

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Oct 24, 2025 Other Medical Devices Nationwide View Details →

MAMMOMAT Fusion;

Siemens Medical Solutions USA

Class I - Dangerous

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Oct 24, 2025 Other Medical Devices Nationwide View Details →

MAMMOMAT Revelation;

Siemens Medical Solutions USA

Class I - Dangerous

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Oct 24, 2025 Other Medical Devices Nationwide View Details →