FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
- Recall number
- Z-0174-2016
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
- Status
- Terminated
- Initiated
- 2015-09-14
- Posted
- not on file
- Terminated
- 2018-06-26
- Reason
- The firm discovered Ring/Dot artifact due to X-ray measurement error.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 108 units
- Distribution
- 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.
- Lot, serial or model codes
- Model No. 728231; S/N: 2, 9030, 9047, 9050, 9152, 9168, 9234, 9250, 9542, 9552, 9627, 9664, 9690, 9801, 9915, 9996, 9999, 10009, 10066, 10196, 10804, 10807, 29009, 29039, 29047, 29049, 29051, 29070, 29135, 29151, 90035, 90056, 90069, 90085, 90156, 90189, 90192, 95054, 95120, 95138, 95164, 95259, 95285, 95345, 95350, 95359, 95403, 95441, 95442, 95470, 95480, 95497, 95498, 95502, 95517, 95521, 95522, 95561, 95633, 95643, 95656, 95695, 95884, 95885, 95886, 95889, 95893, 95894, 95896, 95897, 95898, 95899, 95900, 95901, 95902, 95903, 95904, 95905, 95906, 95907, 95908, 95909, 95910, 95911, 95912, 95913, 95914, 95915, 95916, 95917, 95918, 95919, 95920, 95921, 95922, 95923, 95924, 95925, 95926, 95927, 95928, 95929, 95930, 95931, 95933, 95934, 95936, 95937, 95938, 95940, 95941, 95942, 95944 & 95946.
- 510(k) numbers
- ["K033326"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28