Z-1951-2019Class II

Revolution CT scanners

Name: Z-1951-2019 Revolution CT scanners
Creator: GE Healthcare, LLC
Published: 2019-01-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-01-19 / Open, Classified / root cause: design

FDA source

GE Healthcare, LLC began a recall of Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications on 2019-01-19. FDA classified it as Class II and gives the reason as "Additional low dose radiation exposure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1951-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-19
Posted: 2019-07-12
Recalling firm: GE Healthcare
Product: Revolution CT scanners Product Usage: 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: Additional low dose radiation exposure.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare will send a customer letter that provide safety instructions for immediate mitigation of the issue. The customer can continue to use the system with the recommended workaround instruction provided in the customer letter: All affected systems will be corrected with updated software and a User Manual Addendum which re-emphasizes existing pat ient center ing instructions. If you have any questions or concerns regarding this notification. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 857 (US = 195: OUS = 662)
Distribution: Worldwide - US Nationwide Distribution
Product codes and lots: Revolution CT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1951-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1951-2019	Class II	Ongoing	FDA Mandated	2019-07-24	2019-07-12

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)