Volume Viewer Plus

• • Terminated Z-0901-2013 FDA Class II ·initiated 25 May 2012

  Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.

• • Terminated Z-2312-2008 FDA Unclassified (pre-2012) ·initiated 1 May 2008 ·on shared 510(k) K041521

  GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K041521 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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