Z-0402-2018Class II

Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

Name: Z-0402-2018 Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2017-07-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-07-11 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems on 2017-07-11. FDA classified it as Class II and gives the reason as "Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0402-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-11
Posted: 2018-01-23
Terminated: 2019-07-02
Recalling firm: Philips North America LLC
Product: Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Root cause tag: software
FDA root cause: Software design
Action: A Customer Information Letter dated June 29, 2017, was sent to US consignees via certified mail. 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.
Quantity in commerce: 559 total
Distribution: Worldwide distribution, including US nationwide.
Product codes and lots: Brilliance iCT 4.1.6 version. Brilliance iCT SP - Model 728311 Codes: 200038 200203 200119 200052 200206 200210 200208 200213 200097 200100 200063 200009 200011 200204 200212 200018 200207 200027 200130 83001 200209 200215 200043 200032 200200 200051 200086 200202 200211 200024 200023 200068 200201 200017 200061 200205 200030 200117 200044 200015 83000 200022 200093 200101 200040 200013 200107 200111 200138 200214 200102 200047 200019 200105 200109 200121 200041 200131 200127 200003 200092 200074 200088 200067 200089 200049

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0402-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0402-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-23
Z-0403-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-23

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)