FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
- Recall number
- Z-2524-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
- Status
- Terminated
- Initiated
- 2018-05-30
- Posted
- not on file
- Terminated
- 2020-02-14
- Reason
- During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
- Root cause
- Device Design
- Action
- An Urgent Medical Device Correction notification was distributed to customers on 5/30/18. The notification provided the following information to customers: Siemens will correct the error by inspecting all affected ARTIS Pheno systems. As an immediate measure to prevent movement stops during a C-arm rotation followed by a C-arm drop, the maximum rotation speeds will be reduced. This correction limits the maximum manual LAO/RAO rotation from 25/sec to 20/sec and Cran/Caud rotation from 20/sec to 10/sec. All other system parameters as well as 3D acquisition and Perivision/Peristepping remain unaffected. You may continue to use the ARTIS Pheno system while awaiting implementation of the corrective action. Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction AX004/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. Additionally, Siemens is developing a solution to restore the system back to the original settings. This solution will be distributed to all affected customers upon completion.
- Quantity
- 40 in the United States
- Distribution
- The devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.
- Lot, serial or model codes
- 164033, 164071, 164034, 164095, 164057, 164054, 164055, 164080, 164072, 164088, 164048, 164094, 164068, 164019, 164013, 164073, 164025, 164026, 164027, 164060, 164083, 164021, 164066, 164075, 164074, 164084, 164086, 164098, 164028, 164053, 164063, 164064, 164024, 164049, 164018, 164022, 164061, 164100, 164097, 164011
- 510(k) numbers
- ["K163286"]
- 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