The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission pr
Summary
The FDA issued a Class II for The system is intended to produce cross-sectional images of the body by computer by GE Healthcare, LLC. Reason: When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confi.
Details
Source
Device Recall
External ID
Z-2022-2021
Action Date
2021-07-14
Status
Ongoing
Category
device
Product Description
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
Lot/Code Info: Revolution CT
Reason for Recall
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
Distribution
US
Type: FDA Mandated
Recall Initiated: 2021-06-30
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 413 device-related FDA actions this month.
GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Healthcare, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Healthcare, LLC have FDA actions?
GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2022-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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