FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
- Recall number
- Z-2525-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
- Status
- Terminated
- Initiated
- 2018-05-25
- Posted
- not on file
- Terminated
- 2019-05-16
- Reason
- Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
- Root cause
- Process control
- Action
- Siemens issued on May 25, 2018 an URGENT: MEDICAL DEVICE CORRECTION customer notification to affected customers and advised a hardware update will be initiated . Users advised of the problem, potential risks and action to be taken. Siemens will correct the error by replacing all affected cooling units with Update Instruction AX076/17/S. Users may continue to use the Artis system while awaiting implementation of the corrective action.
- Quantity
- 6 units US
- Distribution
- HI , IL, MI, NC, NY, VA, WI
- Lot, serial or model codes
- Laird Cooling Unit for SSFD: Material # 7555118.
- 510(k) numbers
- ["K021021"]
- PMA numbers
- not on file
- Product code
- JAA
- 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