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Recall Observatory FDA recall evidence

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

April 20, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    reason.device_software_design · v1.0.0

    Software bugs in VC20B SP0a or SP1 software versions may cause issues that could