Software : myNeedle Guide 2D license recall
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed…
Why was Software : myNeedle Guide 2D license recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 29 units U.S.
- Distribution
- Nationwide
- Recall date
- February 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)