Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2018 - (Recall #: Z-1392-2018)

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, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.

Product Classification:

Class II

Date Initiated: February 15, 2018

Date Posted: April 25, 2018

Recall Number: Z-1392-2018

Event ID: 79696

Reason for Recall:

Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.

Status: Terminated

Product Quantity: 12

Code Information:

Serial No: 2090 2072 2077 2079 2086 2091 2093 2085 2076 2071 2078 2081

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated