FDA Device recall Z-2524-2018
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 by Siemens Medical Solutions Usa, citing 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 sy….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2524-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-30 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AL, CA, CO, FL, IL, KY, MA, ME, MI, MN, MS, NJ, NY, OH, TN, TX, UT, VA |
Product
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
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 ).
Identifiers
| code_info | 164033, 164071, 164034, 164095, 164057, 164054, 164055, 164080, 164072, 164088, 164048, 164094,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2524-2018%22
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