• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Recall Number Z-0979-2014
Classification Class II
Code Info 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.
Product Distributed Qty 47 Units
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.

Event Detail

Event Id 67305
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems (Cleveland) Inc
City Cleveland
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
-
-