Z-0955-2015Class II

The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table...

Name: Z-0955-2015 The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table...
Creator: GE Healthcare
Published: 2014-11-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-11-12 / Terminated / root cause: software

FDA source

GE Healthcare began a recall of The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet... on 2014-11-12. FDA classified it as Class II and gives the reason as "A required quality control test was not performed during installation associated with the software of the Revolution CT scanner". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0955-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-12
Posted: 2015-01-26
Terminated: 2015-04-29
Recalling firm: GE Healthcare
Product: The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare Planned Action (s) to repair defect or to bring product into Compliance letter dated January 16, 2015 to GE Healthcare. 1. A GE Healthcare service representative will perform a noise specification and tolerance calibration to correct all affected systems via Field Action Instruction (FMI 25457). 2. A customer notification letter which includes a statement that GE Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. GE Healthcare Surgery will implement this CAP by May 1, 2015. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). Call Center phone numbers: United States: 800 437-1171, Japan: 0120-055-919 Information For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.
Quantity in commerce: 13 units
Distribution: US Distribution to the states of CA, FL, IL, NY, UT and WA.
Product codes and lots: Software version: 14MW14.29

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0955-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0955-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-26

Product code JAK

K133705Class IIRevolution CTGe Medical Systems, LLC / cleared 2014-04-11

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)