| Class 2 Device Recall GEMINI GXL | |
Date Initiated by Firm | February 19, 2009 |
Date Posted | July 06, 2009 |
Recall Status1 |
Terminated 3 on September 21, 2012 |
Recall Number | Z-1579-2009 |
Recall Event ID |
52176 |
510(K)Number | K051170 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase for use on the GEMINI GXL 16 Slice PET/CT System (contains EBW 455011002031 as an accessory), Catalog #882410, Model Number: 4535 679 71891. CT host. 2.2.
Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy. |
Code Information |
GEMINI GXL 16 Slice - Serial Numbers: 4149, 4150, and 4173. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland OH 44143-2131
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For Additional Information Contact | 440-483-7000 |
Manufacturer Reason for Recall | A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units. The software defect results in a the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID. |
FDA Determined Cause 2 | Software design |
Action | An "URGENT - Field Safety Notice" dated February 12, 2009 was sent via FedEx to domestic customers. The notice described the affected products, issue, involved hazard should problem occur and corrective actions for the customer/user. The letter also notified users/customers that a Philips Healthcare Field Service Engineer will contact and visit their site within 6 months to install a TumorLoc upgrade. Notification will also be sent to the international consignees by Philips personnel. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office. |
Quantity in Commerce | 3 units |
Distribution | Worldwide Distribution -- US, Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia. |
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
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