—#124851

Product

Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images 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: K033357
Affected lot / code info: Model #: 728243; 7133, 7170, 7225, 7262, 7265, 7701, 7706, 7779, 7788, 7792, 7797, 7802, 7805, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7816, 7824, 7831, 7832, 7833, 7834 ,7835. Model #728244; 7621, 7636, 7809 & 7844.

Why it was recalled

Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.

Root cause (FDA determination)

Software design

Action the firm took

On 12/4/2013 the firm sent Urgent Medical Device Corrections letters to their customers.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AK, MD, NH, NV, OH, and OR, and the countries of Australia, China, France, India, Indonesia, Italy, Korea, Mexico, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Thailand & United Arab Emirates.

Timeline

Recall initiated: 2013-12-04
Posted by FDA: 2014-01-21
Terminated: 2015-07-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124851. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.