Z-1004-2017Class II

Brilliance iCT

Name: Z-1004-2017 Brilliance iCT
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-11-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-11-25 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray... on 2016-11-25. FDA classified it as Class II and gives the reason as "Failure to correctly document the installation of four M12 Bolts into the system rotor". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1004-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-25
Posted: 2017-01-11
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Failure to correctly document the installation of four M12 Bolts into the system rotor.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Philips sent a Customer Information Letter to their customer. The letter identified the affected product, problem description and actions to be taken by customers. For further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For SUPPORT North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 1
Distribution: The one system was distributed in Canada. There were no government or US distribution.
Product codes and lots: Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1004-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1004-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code JAK

K060937Class IIBrilliance VolumePhilips Medical Systems (Cleveland), Inc. / cleared 2006-06-05

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)