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U.S. Department of Health and Human Services

Class 2 Device Recall GEMINI PET/CT diagnostic imaging systems

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  Class 2 Device Recall GEMINI PET/CT diagnostic imaging systems see related information
Date Initiated by Firm January 26, 2009
Date Posted November 13, 2009
Recall Status1 Terminated 3 on November 24, 2009
Recall Number Z-0260-2010
Recall Event ID 53517
510(K)Number K051170  
Product Classification Emission computed tomography system - Product Code JAK
Product GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170.
Code Information Catalog Numbers: 882390 and 882410; Model Numbers: 4535 679 75691 and 4535 679 71891; and Serial Numbers: 4190 and 4191.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7000
Manufacturer Reason
for Recall
Upper patient pallet component of the recalling firm's Gemini PET/CT system may be thinner than normally required, which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.
FDA Determined
Cause 2
Process change control
Action The firm notified customers with an "URGENT - Field Safety Notice" which was sent to the user/customers via FedEx on 1/26/2009. The letter informs customers of this potential safety hazard; the actions to be taken by the user/customer in order to mitigate risk to patients while undergoing scans; and the actions planned by Philips Medical's Service Engineers in order to correct the problem. The notification refers the user/customers to the applicable sections of their Systems Operations and Systems Information Manuals for a review on procedures for safely loading; unloading; and monitoring patients before, during, and after scanning studies. The notice goes on to inform the customers that replacement parts for the upper patient pallet(s) are on order and that a Philips Healthcare Field Service Engineer will be visiting each customer site within two (2) months in order to replace each affected pallet. Lastly, the notification provides a toll-free telephone number and instructions which the customer can use to contact a local Philips representative if additional information, or assistance is required. The firm's Customer Care Center contact is 1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology.
Quantity in Commerce 2 units
Distribution The recalled products were distributed to customers in the following states within the U. S.: OH, GA, MI, and CA and to customers overseas in: Germany, France Japan, and South Korea.
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 = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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