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Class 2 Device Recall GEMINI TF Big Bore PET/CT, Computed Tomography System |
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Date Initiated by Firm |
December 05, 2013 |
Date Posted |
February 12, 2014 |
Recall Status1 |
Terminated 3 on August 25, 2015 |
Recall Number |
Z-0979-2014 |
Recall Event ID |
67305 |
510(K)Number |
K081135
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Product Classification |
System, tomography, computed, emission - Product Code KPS
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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 OH 44143-2131
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For Additional Information Contact |
Mrs. Kumudini J. Carter 440-483-3032
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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