Z-2021-2021Class II

The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray...

Name: Z-2021-2021 The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray...
Creator: GE Healthcare, LLC
Published: 2021-06-30
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-06-30 / Open, Classified / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of 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... on 2021-06-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2021-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-30
Posted: 2021-07-08
Recalling firm: GE Healthcare
Product: 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.
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Distribution: US
Product codes and lots: Revolution CT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2021-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2021-2021	Class II	Ongoing	FDA Mandated	2021-07-14	2021-07-08
Z-2022-2021	Class II	Ongoing	FDA Mandated	2021-07-14	2021-07-08
Z-2023-2021	Class II	Ongoing	FDA Mandated	2021-07-14	2021-07-08

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)