Z-2524-2018Class II

ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

Name: Z-2524-2018 ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-05-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-05-30 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 on 2018-05-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2524-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-30
Posted: 2018-07-20
Terminated: 2020-02-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2524-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2524-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-20

Product code OWB

K163286Class IIARTIS phenoSiemens Medical Solution USA, Inc. / cleared 2017-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)