Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-2657-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 20, 2016

Date Posted: August 31, 2016

Recall Number: Z-2657-2016

Event ID: 74820

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.

Status: Terminated

Product Quantity: 30

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated