Z-2653-2016Class II

Brilliance CT Big Bore Oncology, Model number 728243

Name: Z-2653-2016 Brilliance CT Big Bore Oncology, Model number 728243
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-07-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-07-20 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by... on 2016-07-20. FDA classified it as Class II and gives the reason as "After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that...". 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-2653-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-20
Posted: 2016-08-25
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: Brilliance CT Big Bore Oncology, Model number 728243 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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
Root cause tag: software
FDA root cause: Software Design Change
Action: Customers were sent a letter dated July 28, 2016 informing them of the problem, under what circumstances it can occur and the actions that the customer can take to minimize the effect of the problem. The letter also includes the actions planned by Philips to correct the problem. Philips plans on releasing a field change order (FCO) to correct the affected systems. If you need any further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377).
Quantity in commerce: 33
Distribution: US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
Product codes and lots: 728243 Brilliance BigBore Oncology CT 7116 7611 7354 7063 7309 7169 7205 7016 7019 7043 7069 7073 7091 7112 7132 7163 7141 7194 7226 7325 7294 7350 7316 7480 7114 7210 7310 7438 7530 7186 7119 7042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2653-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2652-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2653-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2654-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2655-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2656-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2657-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2658-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25

Product code JAK

K033357Class IIAcqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. / cleared 2004-01-09

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)