Food, drugs, devices › Siemens Medical Solutions USA, Inc
Device recall: SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission
FDA enforcement event 79428 is a device recall by Siemens Medical Solutions USA, Inc of Malvern, PA, initiated 15 Feb 2018 and classified Class II, with 15 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 8 Apr 2020. 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
"to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure"
Distribution
"USA (nationally) Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1445-2018 | SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1446-2018 | SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1447-2018 | SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1448-2018 | SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1449-2018 | SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1450-2018 | SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1451-2018 | SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1452-2018 | SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1453-2018 | SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1454-2018 | SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1455-2018 | SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1456-2018 | SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1457-2018 | SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1458-2018 | SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
| Z-1459-2018 | SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | 1301 | Class II | Terminated | 9 May 2018 |
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: "to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure"
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: "USA (nationally) Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Apr 2020. "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.