Z-2657-2016Class II

Ingenuity Core, Model number 728321

Name: Z-2657-2016 Ingenuity Core, Model number 728321
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 Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer... 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-2657-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-20
Posted: 2016-08-25
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: Ingenuity Core, Model number 728321 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: 30
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: 728321 -- Ingenuity Core 310004 310005 310012 310016 310020 310021 310027 310028 310033 310034 310041 310044 310045 310057 310061 310065 310072 310074 310076 310077 310078 310094 310099 310100 310103 310105 310117 310120 310122 310135

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2657-2016
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

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

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)