Artis icono floor-angiography systems developed for single… recallZ-1246-2022 · Siemens Medical Solutions USA, Inc · initiated Apr 11, 2022
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
FDA root cause category: Device Design
What the company is doing
Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via AX027/21/S on 4/11/22. Siemens will conduct an inspection of the protective earth via Update Instruction AX026/21/S. 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. Acknowledge Receipt of this Safety Advisory Notice 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-1246-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 11, 2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 13 units
- Product code
- OWB
- FDA submissions
- K190768, K193326
- Distribution
- US Nationwide distribution.
Product description
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
Code information (models, lots, serial numbers)
UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
Other devices under the same FDA submission
1 device cleared under K190768, K193326 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90184).
- Z-1245-2022 · Open, ClassifiedArtis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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