Food, drugs, devices › Siemens Medical Solutions USA, Inc
Device recall: SOMATOM Confidence -Computed tomography systems Model 10590100
Siemens Medical Solutions USA, Inc (Malvern, PA) initiated this device recall on 19 Nov 2021; FDA lists 4 product records under event 89208, classified Class II.
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. 89% of the 900 device enforcement events initiated in 2021 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
"Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0472-2022 | SOMATOM Confidence -Computed tomography systems Model 10590100 | 108 units | Class II | Ongoing | 19 Jan 2022 |
| Z-0473-2022 | SOMATOM Definition AS-Computed tomography system Model 8098027 | 794 units | Class II | Ongoing | 19 Jan 2022 |
| Z-0474-2022 | SOMATOM Edge Plus-Computed tomography system Model 1026700 | 80 units | Class II | Ongoing | 19 Jan 2022 |
| Z-0475-2022 | SOMATOM Definition Edge -Computed tomography system Model 10590000 | N/A | Class II | Ongoing | 19 Jan 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: "Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis."
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.