Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2013 - (Recall #: Z-0950-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Product Classification:

Class II

Date Initiated: February 15, 2013

Date Posted: March 20, 2013

Recall Number: Z-0950-2013

Event ID: 64436

Reason for Recall:

This field change order is being released to update software and customer release notes to the affected installed base.

Status: Terminated

Product Quantity: 42 Units

Code Information:

Brilliance 64: 728231 & Ingenuity CT: 728326, 728323. System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code # 728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300014,300015,300018,300027,300041,300053,300059,300066,300070,300071,300073,300074,300078,300079,300080,300082,300084,300086,300091,300095,300101,300102,300112,300127,300128,300129,300131,300132,310064 System Code # 728323, Serial #: 320033

Distribution Pattern:

Worldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, Germany, Israel, Japan, Norway, Sweeden, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated