FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
- Recall number
- Z-1245-2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
- 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
- 51 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 04056869063317 Serial Number: 180062 180054 180019 180065 180056 180057 180041 180317 180034 180072 180060 180070 180048 180083 180315 180080 180301 180305 180067 180330 180040 180333 180029 180336 180316 180084 180334 180018 180046 180047 180335 180085 180035 180081 180331 180021 180321 180309 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037
- 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