Z-0332-2018Class II

Philips Healthcare Brilliance iCT SP computed tomography x-ray system

Name: Z-0332-2018 Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2017-11-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-11-08 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Philips Healthcare Brilliance iCT SP computed tomography x-ray system on 2017-11-08. FDA classified it as Class II and gives the reason as "There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0332-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-08
Posted: 2018-01-11
Terminated: 2020-04-17
Recalling firm: Philips North America LLC
Product: Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Root cause tag: design
FDA root cause: Device Design
Action: Philips Healthcare is informing consignees of this issue through a Customer Information Letter (CIL_FCO72800690). Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Customers are notified that if they hear an unusual noise coming from the gantry, or scan halts, the Philips representative should be contacted as soon as possible. Philips will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost.
Quantity in commerce: 134
Distribution: 107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
Product codes and lots: Brilliance iCT SP - 728311 Devices manufactured 03/05/2009 to present.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0332-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0331-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-11
Z-0332-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-11
Z-0333-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-11

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)