FDAClass IIFebruary 4, 2015

The Revolution CT is a multi-slice recall: Software Issue

The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system…

Why was The Revolution CT is a multi-slice recalled?

A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Software version: 14MW14.29

Product
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system…
Recalling firm
GE Healthcare
Quantity
13 units
Distribution
US Distribution to the states of CA, FL, IL, NY, UT and WA.
Recall date
February 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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