Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2018 - (Recall #: Z-0522-2018)

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:

Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system

Product Classification:

Class II

Date Initiated: November 1, 2017

Date Posted: February 14, 2018

Recall Number: Z-0522-2018

Event ID: 79004

Reason for Recall:

One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.

Status: Terminated

Product Quantity: 2

Code Information:

Ingenuity TF PET/CT Model # 882442

Distribution Pattern:

One domestic and 1 foreign consignee ( Spain)

Voluntary or Mandated:

Voluntary: Firm initiated