Z-2283-2018Class II

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

Name: Z-2283-2018 ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-05-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-05-01 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000 on 2018-05-01. FDA classified it as Class II and gives the reason as "If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 )...". 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-2283-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-01
Posted: 2018-06-22
Terminated: 2020-03-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
Root cause tag: design
FDA root cause: Device Design
Action: On May 1, 2018, the firm distributed Urgent Medical Device Correction letters to its affected customers. The letter instructed customers to follow standard emergency procedures they have in place in the event of system failures. The firm recommended considering reinforcing the emergency procedures until the update has been completed. As an immediate measure, operators were instructed to avoid driving the C-arm into a fully extended longitudinal position. The firm is currently developing a solution to eliminate the root cause of the problem. The solution will be distributed to all affected customers upon completion. Customers were asked to forward the safety information to any other organizations that could be affected.
Quantity in commerce: 39
Distribution: Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: 164033 164071 164034 164095 164057 164055 164054 164080 164072 164088 164048 164094 164068 164019 164013 164073 164027 164026 164025 164060 164083 164021 164066 164075 164084 164086 164074 164098 164028 164053 164063 164064 164024 164049 164022 164018 164100 164097 164011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2283-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2283-2018	Class II	Completed	Voluntary: Firm initiated	2018-07-04	2018-06-22

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)