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U.S. Department of Health and Human Services

Class 2 Device Recall GEMINI TF Big Bore PET/CT, Computed Tomography System

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 Class 2 Recall
GEMINI TF Big Bore PET/CT, Computed Tomography System
see related information
Date Posted February 12, 2014
Recall Status1 Open
Recall Number Z-0979-2014
Recall Event ID 67305
Premarket Notification
510(K) Number
K081135 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Code Information 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.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
For Additional Information Contact Mrs. Kumudini J. Carter
440-483-3032
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
Action ON 12/5/2013 the firm sent Medical Device Correction Letters to their customers.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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