Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2017 - (Recall #: Z-1058-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Brilliance iCT

Product Classification:

Class II

Date Initiated: December 23, 2016

Date Posted: February 1, 2017

Recall Number: Z-1058-2017

Event ID: 76144

Reason for Recall:

During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.

Status: Terminated

Product Quantity: 1-unit

Code Information:

Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203

Distribution Pattern:

Product was not distributed in the US. Unit was distributed in Australia.

Voluntary or Mandated:

Voluntary: Firm initiated