Z-0776-2019Class II

Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and...

Name: Z-0776-2019 Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and...
Creator: GE Healthcare, LLC
Published: 2018-07-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-07-12 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications on 2018-07-12. FDA classified it as Class II and gives the reason as "On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0776-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-07-12
Posted: 2019-02-06
Recalling firm: GE Healthcare
Product: Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare sent a Notification letter dated October 18, 2018 to affected customers and sent a second letter dated October 30, 2018. The letters identified the affected product, problem and actions to be taken. The customers were instructed to do the following: ensure that all potential users in your facility are made aware of this notification and the recommended action, also stated: To avoid the issue, only use the 'In' button on the gantry controls and follow this required workflow: 1. Move the table back into the gantry using the 'In' button on the gantry controls . 2. Verify that the needle position is aligned using the internal laser alignment light. GE Healthcare will correct both forward production and impacted customer devices with a software update. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 131 units
Distribution: Worldwide Distribution - US (Nationwide Distribution) and countries of: Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: SmartStep Option

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0776-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0776-2019	Class II	Ongoing	FDA Mandated	2019-02-13	2019-02-06

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)