—#148523

Product

Brilliance CT 16 Power, Model number 728240 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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009
Affected lot / code info: 728240 -- Brilliance CT 16 Power 3100 5043 5047 5280 5345 5390 5413 5430 5495 5499 5512 6007 6009 6013 6032 6041 6045 6049 6051 6058 6064 6066 6070 6071 6077 6080 6081 6084 6089 6095 6100 6106 6109 6113 6115 6116 6123 6124 6131 6132 6134 6141 6144 6155 6161 6162 5476 6098 6120 6067

Why it was recalled

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 (FDA determination)

Software Design Change

Action the firm took

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).

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

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

Timeline

Recall initiated: 2016-07-20
Terminated: 2018-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148523. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.