Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2015 - (Recall #: Z-2194-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Product Classification:

Class II

Date Initiated: July 1, 2015

Date Posted: July 29, 2015

Recall Number: Z-2194-2015

Event ID: 71699

Reason for Recall:

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Status: Terminated

Product Quantity: 2 units

Code Information:

Model #882412 GEMINI LXL (459800018631); Serial Number: 14702 & 14707.

Distribution Pattern:

Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated