FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
- Recall number
- Z-1246-2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
- Status
- Open, Classified
- Initiated
- 2022-04-11
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 13 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053
- 510(k) numbers
- ["K190768","K193326"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28