Z-0816-2022Class II

Revolution CT, Revolution CT ES

Name: Z-0816-2022 Revolution CT, Revolution CT ES
Creator: GE Healthcare, LLC
Published: 2021-06-30
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-06-30 / Open, Classified

FDA source

GE Healthcare, LLC began a recall of Revolution CT, Revolution CT ES on 2021-06-30. FDA classified it as Class II and gives the reason as "The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0816-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-30
Posted: 2022-04-05
Recalling firm: GE Healthcare
Product: Revolution CT, Revolution CT ES
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take. GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Services at 1 (800) 437-1171 or local Service Representative.
Quantity in commerce: 273 (51 US; 222 OUS) in total
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Revolution CT, Revolution CT ES

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0816-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0815-2022	Class II	Ongoing	FDA Mandated	2022-04-13	2022-04-05
Z-0816-2022	Class II	Ongoing	FDA Mandated	2022-04-13	2022-04-05

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)