Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Why it was recalled
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / 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
Recall status
Ongoing — the recall is still being carried out.
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.
Recall record
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product type
- Devices
- Recall number
- Z-1469-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Malvern, PA
- Recall initiated
- 2023-03-21
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1469-2023 · Source: openFDA enforcement.