Drug recall
SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray…
FDA recall event 79428 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 79428 |
|---|---|
| Recall numbers | Z-1445-2018, Z-1446-2018, Z-1447-2018, Z-1448-2018, Z-1449-2018, Z-1450-2018, Z-1451-2018, Z-1452-2018, Z-1453-2018, Z-1454-2018, Z-1455-2018, Z-1456-2018 and 3 more |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data., SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data., SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data., SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data., SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. and 10 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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…, 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… |
| Initiation date | Feb 15, 2018 |
| Report date | May 9, 2018 |
| Termination date | Apr 8, 2020 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
At a glance
- 10–99 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: