CLASS II ONGOING Device recall · Reported 3 May 2023 · FDA Enforcement Report

Artis one with a hybrid cable- An angiography system recalled

Siemens Medical Solutions USA is recalling Artis one with a hybrid cable- An angiography system developed for diagnostic imaging and, distributed nationwide in the US. The recall was initiated on 21 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled4 units US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1469-2023
FDA event ID: 92118
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Mar 2023
FDA classified: 27 Apr 2023
Reported: 3 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

21 Mar 2023	Recall initiated by company
27 Apr 2023	Classified by FDA	+37 days
3 May 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Florida Georgia Puerto Rico South Dakota

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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