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FDA (Device enforcement)Recalled 2022-12-22class ii

Siemens Medical Solutions USA, Inc: Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography syste

Hazard

In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped

Details from the source

Reason for recall: In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped Distribution: Nationwide Quantity: 29 units U.S. Lot/code info: UDI: 04056869151571, 04056869051314, 04056869151564, 04056869151571, 04056869231044 04056869231051, 04056869249247, 04056869263168, ¿04056869051314 S/N: Serial Number 112285 112443 117977 117982 119197 123059 123206 123222 123225 123233 123236 123261 123273 123281 123306 123310 123327 123329 125051 125067 127089 130121 172649 172758 172820 172914 172925 172949 172956

UPC codes

04056869151571, 04056869051314, 04056869151564, 04056869231044, 04056869231051, 04056869249247, 04056869263168

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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