Recalls / —

—#138615

Product

Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. 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

K060937

Affected lot / code info

Brilliance iCT: Model #728306; Serial #s: 85012, 85013, 85014, 100029, 100038, 100040, 100053, 100058, 100094, 100099, 100133, 100140, 100162, 100178, 100236, 100244, 100373, 100399, 100408, 100411, 100416, 100441, 100450, 100454, 100461, 100463, 100465, 100466, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100512, 100517 & 100518.

Why it was recalled

5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict

Root cause (FDA determination)

Software change control

Action the firm took

On 2/5/2015 the firm sent Customer Information 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-US (nationwide) including the states of AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV & WY, and to the following countries: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Timeline

Recall initiated

2015-02-05

Posted by FDA

2015-07-24

Terminated

2018-06-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #138615. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.