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U.S. Department of Health and Human Services

Class 2 Device Recall GEMINI Big Bore PET & XRay CT scanning systems

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  Class 2 Device Recall GEMINI Big Bore PET & XRay CT scanning systems see related information
Date Initiated by Firm October 24, 2012
Date Posted February 26, 2013
Recall Status1 Terminated 3 on July 23, 2015
Recall Number Z-0883-2013
Recall Event ID 63822
510(K)Number K081135  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Code Information The affected GEMINI Big Bore system is identified with the following Serial Numbers: 9004, 9005, 9006, 9008 ,9009, 9010, 9011, 9012, 9013, 9014, 9014, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9205, 9206, 9207, 9208, 9209, 9210, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, and 9221.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Michael McAndrew
800-722-9377
Manufacturer Reason
for Recall		 Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
FDA Determined
Cause 2		 Software design
Action Philips Medical issued an URGENT - Medical Device Correction letter to their customers concerning the Tumor LOC IPD issue on October 25, 2012. The letter informs the customer of the nature of this software problem and names the Brilliance and GEMINI scanning systems affected by this issue. The letter goes on to describe the hazard inherent to this software issue and provides 'Workaround procedures which the customers can use in order to help mitigate the effects of this problem. Customers with questions should contact their Customers Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 1-800-722-9377.
Quantity in Commerce 37
Distribution Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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