Philips North America Llc: Medical Device Recall in 2021 - (Recall #: Z-1774-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

Product Classification:

Class II

Date Initiated: April 13, 2021

Date Posted: June 9, 2021

Recall Number: Z-1774-2021

Event ID: 87872

Reason for Recall:

Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury

Status: Terminated

Product Quantity: 2 units (1 US and 1 OUS)

Code Information:

Serial Numbers: 100100, 100434

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated