Revolution CT with Apex Edition CT System - Product recall
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Why was Revolution CT with Apex Edition CT System - Product recalled?
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
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?
Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).
- Product
- Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 3 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
- Recall date
- December 30, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)