PlainRecalls
FDA Devices Moderate Class II Terminated

GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

Reported: February 19, 2014 Initiated: December 5, 2013 #Z-0979-2014

Product Description

GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

Reason for Recall

The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.

Details

Units Affected
47 Units
Distribution
Product was shipped to the following states: AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT & WI. Product was also shipped to the following countries: Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia & Venezuela.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 47 Units.
Why was this product recalled?
The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 19, 2014. Severity: Moderate. Recall number: Z-0979-2014.