Z-1058-2017Class II

Brilliance iCT

Name: Z-1058-2017 Brilliance iCT
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-12-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-12-23 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT on 2016-12-23. FDA classified it as Class II and gives the reason as "During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued". 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-1058-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Posted: 2017-01-20
Terminated: 2018-06-26
Recalling firm: Philips North America LLC
Product: Brilliance iCT
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Philips sent an Customer Information letter. A document showed an incorrect torque wrench used during the assembly process which could potentially apply 4 Newton-meters less torque than specified to the system rotor counterweight bolts. Out of an abundance of caution, Philips will have a Field Service Engineer ensure the bolts on your system are correctly torqued. If you need any further information or support concerning this issue, please contact your local Philips representative. For further information please call (440) 483-5777.
Quantity in commerce: 1-unit
Distribution: Product was not distributed in the US. Unit was distributed in Australia.
Product codes and lots: Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1058-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1058-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20

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)