FDAFDA · Food and drugs·Recall number Z-0979-2014
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Published February 19, 2014 · Recall initiated: December 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- 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.
- Lot
- Model #882476, Serial #'s: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9228, 9229, 9231.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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