Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-2367-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Product Classification:

Class II

Date Initiated: March 24, 2016

Date Posted: August 17, 2016

Recall Number: Z-2367-2016

Event ID: 73750

Reason for Recall:

Software defect causing intermittently slow response of Host.

Status: Terminated

Product Quantity: 8 units

Code Information:

Model #: 728243; Serial #s: 7063, 7116, 7169, 7205, 7309, 7314, 7354, 7611.

Distribution Pattern:

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Voluntary or Mandated:

Voluntary: Firm initiated