Z-0335-2014Class II

Brilliance iCT Computed Tomography X-Ray System

Name: Z-0335-2014 Brilliance iCT Computed Tomography X-Ray System
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2013-10-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-10-11 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional... on 2013-10-11. FDA classified it as Class II and gives the reason as "If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or...". 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-0335-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-11
Posted: 2013-11-15
Terminated: 2015-08-04
Recalling firm: Philips North America LLC
Product: Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.
Root cause tag: design
FDA root cause: Device Design
Action: Philips sent an Urgent - Medical Device Correction letter dated October. 11, 2013, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue the use of the footrest extension. Philips also, stated they will replace the old footrest extension with the current one in use. For questions contact your local Philips representative or local Philips Healthcare office.
Quantity in commerce: 9 units
Distribution: Worldwide distribution: USA (nationwide) Distribution in the states of DC, GA, IL, IN, NY and OH and the countries: Germany, Israel and Netherlands.
Product codes and lots: Model #728306, Serial #'s: 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024 and 100025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0335-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0335-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15

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)