—#106956

Product

Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. Computed Tomography X-Ray System intended to produce 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, Serial # 7006, 7009, 7060, 7068, 7081, 7095, 7122, 7127, 7133, 7150, 7154, 7185, 7233, 7245, 7278, 7285, 7298, 7337, 7395, 7400, 7450, 7465, 7468, 7506, 7518, 7520, 7521, 7523, 7524, 7528, 7545, 7547, 7560, 7568, 7569, 7573, 7578, 7581, 7584, 7591, 7593, 7597-7599, 7602, 7611, 7616, 7617, 7618, 7620, 7622-7635, 7637-7650, 7652, 7655-7659, 7661-7663, 7665-7667, 7671-7675, 7677-7682, 7684-7687, 7689-7691, 7693, 7695, 7696, 7698-7707, & 75000. Model # 728244, Serial # 7543, 7571, 7600, 7619, 7621, 7636, 7651, 7653, 7654, 7660, 7668-7670, 7676, 7683, 7688, 7694, 7697, 7708, & 7710.

Why it was recalled

The Block and Multi Leaf Collimator (MLC) shape is not propagated to the beam that is modified by the Oppose operation. The contours can appear with the incorrect color in the Beam's Eye View Viewer, resulting in organs being incorrectly placed or incorrectly shaped.

Root cause (FDA determination)

Software design

Action the firm took

On 12/13/2011, the firm sent Field Safety Notices, entitled URGENT - Medical Device Correction, to their customers. The letter identified the affected product, the problem, the hazard involved, and the actions to be taken by customers and the firm. Customers were to follow the instructions provided in order to address or avoid the issues. Philips will be installing a software update to address the identified issues free of charge. If customers need further information or support in regards to these issues, they are to contact their local Philips representative or local Philips Healthcare office. In North America and Canada, customers can contact the Customer Care Solutions Center at 1-800-722-9377.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NM, NY, OH, OR, PA, PR, TN, TX, VA, & WA and countries of AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, DOMINICAN REPUBLIC, FRANCE, GABON, GERMANY, HUNGARY, ISRAEL, ITALY, JORDAN, LUXEMBOURG, MALI, MEXICO, NETHERLANDS, OMAN, SLOVAKIA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UKRAINE, UNITED ARAB EMIRATES, & UNITED KINGDOM.

Timeline

Recall initiated: 2011-12-13
Posted by FDA: 2012-02-03
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106956. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.