Z-2524-2018 Class II Terminated
FDA device recall Z-2524-2018 was initiated by Siemens Medical Solutions USA, Inc on May 30, 2018 and is designated Class II. 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… The recall status is terminated (terminated Feb 14, 2020). Affected quantity: 40 in the United States.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2018
- Initiation Date
- May 30, 2018
- Termination Date
- Feb 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 in the United States
Product Description
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
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 ).
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2524-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026