—#107891

Product

Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Model # 728243, Serial # 5005, 7006-7009, 7013-7051, 7053-7062, 7064-7120, 7122-7123, 7125-7158, 7160-7166, 7168-7171, 7173-7175, 7177-7179, 7181, 7183-7189, 7191-7199, 7201-7243, 7245-7251, 7253, 7255-7267, 7269, 7270, 7272-7295, 7297-7300, 7302-7304, 7306-7317, 7319-7374, 7376-7379, 7381, 7382, 7384, 7385, 7387-7389, 7392, 7393, 7395, 7397-7401, 7403-7406, 7409-7420, 74227426, 7428, 7429, 7431-7438, 7440-7451, 7454-7457, 7459, 7461-7473, 7475, 7477-7485, 7487-7509, 7511-7513, 7515, 7516-7528, 7530-7532, 7534-7537, 7539-7569, 7571, 7573, 7574, 7576-7582, 7584, 7585, 7588-7593, 7596-7603, 7605-7509, 7611-7613, 7615, 11683, 11698 & 75000. Model # 728244, Serial # 7121, 7439, 7514, 7529, 7538, 7543, 7572, 7575, 7595, 7604, 7621, 7625, 7631, 7632, 7651 & 7654.

Why it was recalled

TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

Philips sent an Urgent - Medical Device Correction letters to all affected customers. The letter identified the product, what the problem is and under what circumstances it can occur, important information for the continued safe and proper use of the affected equipment, and actions to be taken to minimize the effect of the problem. Philips instructed their customers to put a copy of the letter with their "Instructions for Use" manual. For question 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, option 5: Enter Site Id or follow the prompts).

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY. Product was also shipped to the following countries: Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakstan, Kenya, Kuwait, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom & Venezuela.

Timeline

Recall initiated: 2012-01-26
Posted by FDA: 2012-04-05
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107891. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.