Device product
SOMATOM Emotion 16, 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-1645-2015
Product summary
- Event
- Event 71101
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75
- Official record key
device-enforcement:Z-1645-2015
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 16 (2007) 10165977 with serial numbers: 86514 32490 80553 32552 32530 86406 86558 80542 80461 86405 32512 80441 86431 80467 86425 80442 86429 86557 80434 32581 32637 32597 80448 80431 32624 32469 80446 32578 80430
Distribution pattern: Nationwide Distribution including Puerto Rico.
Derived failure modes
-
Device software or design
Software bugs in VC20B SP0a or SP1 software versions may cause issues that could