—#140471

Product

Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

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 No. 728243; S/N: 7007, 7013, 7015, 7020, 7023, 7028, 7059, 7061, 7072, 7083, 7086, 7087, 7101, 7123, 7124, 7128, 7158, 7170, 7173, 7178, 7193, 7204, 7214, 7221, 7228, 7231, 7235, 7246, 7262, 7265, 7273, 7284, 7328, 7347, 7353, 7364, 7365, 7370, 7395, 7400, 7403, 7434, 7435, 7462, 7467, 7481, 7484, 7596, 7612, 7775, 7794, 7795, 7803, 7840, 7841, 7842, 7843, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7853, 7854, 7855, 7856, 7857, 7858, 7859, 7860, 7861, 7863, 7864, 7865, 7866, 7867, 7868, 7869, 7872, 7873, 7875, 7876, 7877, 7881, 7883, 7884, 7885, 7886, 7888, 7889, 7890, 7891, 7892, 7893, 7895, 7896, 7898, 7900, 7901, 7902, 7904, 7905, 7907, 7908, 7909, 7910, 7911, 7914, 7916, 7918, 7920, 7921, 7923, 7924, 7925, 7927, 7928, 7929, 7931, 7932, 7933, 7935, 7936, 7937, 7938, 7939, 7940, 7941, 7942, 7943, 7944, 7945, 7946, 7948, 7949, 7950, 7953, 7954, 7955, 7956, 7960, 7961, 7962, 7963, 7968, 7969, 7970, 7971, 7972, 7973, 7974, 7975, 7976, 7977, 7978, 7980, 7981, 7982, 7983, 7984, 7985, 7987, 7989, 7990, 7991, 7992, 7993, 7994, 7995, 7996, 7997, 7998, 7999, 8000, 8001, 8002, 8004, 8005, 8006, 8007, 75002, 75003, 75004, 75005, 75006, 75007, 75008, 75009, 75010, 75011, 75012, 75013, 75014, 75015, 75016, 75017, 75018, 75019, 75020, 75021, 75022, 75023, 75024, 75025, 75026, 75027, 75028, 75029, 75031, 75032, 75033, 75034, 75035, 75036, 75037, 75039, 75040, 75041, 75042, 75043, 75044, 75046, 75047, 75048, 75049, 75050, 75054, 75060, 75065, 75100, 75102, 75104, 75108 & 750002. Model No. 728244; S/N: 7121, 7176, 7271, 7595, 7764, 7844, 7845, 7862, 7870, 7871, 7874, 7878, 7879, 7880, 7882, 7887, 7894, 7897, 7899, 7903, 7906, 7912, 7913, 7915, 7917, 7919, 7922, 7926, 7930, 7934, 7952, 7957, 7958, 7959, 7964, 7965, 7967, 7979, 7981, 7986, 7988, 75106 & 75110.

Why it was recalled

The firm discovered Ring/Dot artifact due to X-ray measurement error.

Root cause (FDA determination)

Software design

Action the firm took

On 9-23-2015 the firm sent URGENT Field Safety Notices to their customers. The letter identified the products, problem, and actions to be taken by the 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 DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Timeline

Recall initiated: 2015-09-14
Terminated: 2018-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140471. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.