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U.S. Department of Health and Human Services

Class 2 Device Recall Gemini GXL PET/CT scanner

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  Class 2 Device Recall Gemini GXL PET/CT scanner see related information
Date Initiated by Firm August 18, 2005
Date Posted October 21, 2005
Recall Status1 Terminated 3 on October 29, 2008
Recall Number Z-0068-06
Recall Event ID 33273
510(K)Number K042935  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.)
Code Information serial numbers 4001-4019.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact Melinda Novatny
440-483-4255
Manufacturer Reason
for Recall		 The image balance center point correction algorithm used in CT image reconstruction may cause a disapperance or alteration of small circular anatomical structures that are both near the image center and perpendicular to the image plane. This artifact may lead to the misinterpretation of anatomy at the center of the image.
FDA Determined
Cause 2		 Other
Action The recalling firm sent a recall/field correction letter, dated August 18, 2005 to customers, notifying them of the problem.
Quantity in Commerce 19 devices
Distribution The product was distributed to customers within the US and to foreign customers located in Canada, France, Thailand, South Africa, and Italy.
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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