FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
- Recall number
- Z-0708-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
- Status
- Terminated
- Initiated
- 2017-06-06
- Posted
- not on file
- Terminated
- 2019-05-16
- Reason
- Potential for liquid entry
- Root cause
- Device Design
- Action
- On June 6, 2017, Siemens Healthineers distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via USPS Certified Mail. Siemens conducted a corrective field action in June 2015 to protect the Artis table against liquid entry at critical locations. However, even with this corrective action, if there are larger amounts of liquid on the table surface, they can still enter the table. Siemens Medical Solutions USA, Inc. will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment by calling 610-448-6461.
- Quantity
- not on file
- Distribution
- U.S. Nationwide
- Lot, serial or model codes
- 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848353, 10848354, 10848355, 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, 7728392
- 510(k) numbers
- ["K052202"]
- 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