Food, drugs, devices › Siemens Medical Solutions USA, Inc
Device recall: Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedur
FDA enforcement event 90184 is a device recall by Siemens Medical Solutions USA, Inc of Malvern, PA, initiated 11 Apr 2022 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Siemens Medical Solutions USA, Inc has 400 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Medical Solutions USA, Inc, Malvern, PA.
Reason for recall
"if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm"
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1245-2022 | Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600 | 51 units | Class II | Ongoing | 15 Jun 2022 |
| Z-1246-2022 | Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700 | 13 units | Class II | Ongoing | 15 Jun 2022 |
Context
Other enforcement events for Siemens Medical Solutions USA, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Jun 2026 | ARTIS icono ceiling. Model Number: 11328100. | Device | Class II | 1 |
| 20 May 2026 | ARTIS icono biplane. Model Number: 11327600. | Device | Class II | 3 |
| 12 Mar 2026 | ARTIS Pheno VE30A and VE40A, Model 10849000 | Device | Class II | 1 |
| 10 Mar 2026 | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. | Device | Class II | 1 |
| 9 Mar 2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | Device | Class II | 2 |
| 29 Dec 2025 | Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Vers | Device | Class II | 2 |
| 19 Dec 2025 | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | Device | Class II | 4 |
| 5 Dec 2025 | LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 | Device | Class II | 1 |
| 24 Oct 2025 | MAMMOMAT Revelation; | Device | Class II | 3 |
| 1 Oct 2025 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | Device | Class I | 1 |
All 400 events for Siemens Medical Solutions USA, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.