Z-2004-2021Class II

Revolution CT

Name: Z-2004-2021 Revolution CT
Creator: GE Healthcare, LLC
Published: 2021-03-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-03-19 / Completed

FDA source

GE Healthcare, LLC began a recall of Revolution CT on 2021-03-19. FDA classified it as Class II and gives the reason as "GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-2004-2021
Classification: Class II
Status: Completed
Initiated: 2021-03-19
Posted: 2021-07-08
Recalling firm: GE Healthcare
Product: Revolution CT
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare will perform an initial site assessment and replace the collimator, if needed. This will be followed by bi-weekly remote monitoring of the system s log file. Finally, GE Healthcare will install a currently under development software patch, added to the daily fast calibration to automatically and reliably detect this failure should it occur. All of these actions will be performed at no cost to the customer. For questions call 262-544-3217.
Quantity in commerce: 197 (US = 40; OUS = 157)
Distribution: Worldwide distribution - US Nationwide
Product codes and lots: 5590000 5590000-6 5590000-2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2004-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2004-2021	Class II	Completed	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)