Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2018 - (Recall #: Z-0331-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Philips Healthcare Brilliance iCT computed tomography x-ray system

Product Classification:

Class II

Date Initiated: November 8, 2017

Date Posted: January 17, 2018

Recall Number: Z-0331-2018

Event ID: 78879

Reason for Recall:

There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

Status: Terminated

Product Quantity: 702

Code Information:

Brilliance iCT - 728306 Devices manufactured 03/05/2009 to present.

Distribution Pattern:

107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts

Voluntary or Mandated:

Voluntary: Firm initiated