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Z-2283-2018 Class II

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-2283-2018 was initiated by Siemens Medical Solutions USA, Inc on May 1, 2018 and is designated Class II. 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… Affected quantity: 39.

Recall Details

Product Type: Devices
Report Date: Jul 4, 2018
Initiation Date: May 1, 2018
Termination Date: Mar 18, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 39

Product Description

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

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.

Distribution Pattern

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.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2283-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.