Z-1144-2019Class II

Brilliance iCT, 728306

Name: Z-1144-2019 Brilliance iCT, 728306
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-07-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-07-03 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of... on 2018-07-03. FDA classified it as Class II and gives the reason as "Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the...". 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-1144-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-03
Posted: 2019-04-13
Terminated: 2020-04-17
Recalling firm: Philips North America LLC
Product: Brilliance iCT, 728306 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
Root cause tag: design
FDA root cause: Device Design
Action: On June 29. 2018, the firm sent Customer Information Letters to affected customers. The letter informed customers that Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. Customers were advised to review the user documentation provided with your system related to Quality Assurance checks. If artifacts are detected during review of the images produced by these checks, and are not removed with the recommended steps identified within your user documentation, please contact your service representative before resuming clinical use.
Quantity in commerce: 2
Distribution: Distributed only to China and UK.
Product codes and lots: 85028 100094

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1144-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1142-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-13
Z-1143-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-13
Z-1144-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-13

Product code JAK

K162838Class IIPhilips iCT CT SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2017-04-07

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)