Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2013 - (Recall #: Z-1588-2013)

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 CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.

Product Classification:

Class II

Date Initiated: March 21, 2013

Date Posted: July 3, 2013

Recall Number: Z-1588-2013

Event ID: 65137

Reason for Recall:

If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol

Status: Terminated

Product Quantity: 50 units

Code Information:

The following codes are affected by this recall:System Code #728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code #728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300013, 300014,300015,300018, 300027,300041,300053,300054, 300059, 300066, 300070,300071, 300073, 300074, 30077, 300078, 300079, 300080,300082,300084,300086,300091,300092, 300095, 300101, 300102,300112, 300119, 300127, 300128, 300129, 300131, 300132, 310064, 320030 System Code #728321, Serial #: 310096, 310070 System Code #728323, Serial #: 320033

Distribution Pattern:

Nationwide Distribution-including the states of AR, AZ, DE, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, and WY.

Voluntary or Mandated:

Voluntary: Firm initiated