Device product
SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Z-1644-2015
Product summary
- Event
- Event 71101
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75
- Official record key
device-enforcement:Z-1644-2015
Official wording
Reason: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
Code information: SOMATOM Emotion 6 (2007) - 10165888 with serial numbers: 29338 27232 27230 27231
Distribution pattern: Nationwide Distribution including Puerto Rico.
Derived failure modes
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Device software or design
Software bugs in VC20B SP0a or SP1 software versions may cause issues that could