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U.S. Department of Health and Human Services

Class 2 Device Recall Symbia Intevo 6

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  Class 2 Device Recall Symbia Intevo 6 see related information
Date Initiated by Firm November 07, 2017
Create Date November 16, 2017
Recall Status1 Terminated 3 on April 29, 2019
Recall Number Z-0094-2018
Recall Event ID 78184
510(K)Number K162337  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles.SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Code Information Serial Number: 2141, 2144
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates IL 60192-2061
For Additional Information Contact
847-304-7700
Manufacturer Reason
for Recall		 The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
FDA Determined
Cause 2		 Software design
Action Siemens Healthineers sent a Customer Safety Advisory Notice Letter to each impacted consignee beginning on November 07, 2017. Depending on the customer's capabilities, Siemens provides the letters via mail, e-mail, or hand delivery by a service engineer. The receipt of the letter will be documented and additional attempts will be made until such receipt is acknowledged. Certified mail will be used to track the submission of the letter. Certified mail receipts will be obtained for each customer. Adobe e-signature will be obtained from the customers receiving the Customer Advisory Letter via email. Unsuccessful delivery will be documented and a field service engineer will be dispatched to the site to deliver the letter and applicable information. Customers were advised to please ensure that this customer advisory notice is placed in your system with the Broad Quantification option Operators Manual and disseminated to all operators of the system with the Broad Quantification option system. If this equipment is no longer in your possession, we kindly ask that you forward this letter to the new owner of the equipment, and please inform Siemens about the change in ownership. Adverse events or quality problems experienced with the use of this product should be reported to Siemens through the contact information provided below and may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you have any questions regarding this advisory notice, please contact your local Siemens representative at the contact numbers provided below. " America: 1-800-888-7436 " Europe, Middle East, and Africa: +49 9131 940 4000 " Asia and Australia: +86 (21) 3811 2121
Quantity in Commerce 2 units
Distribution Worldwide Distribution to Malaysia, France, Japan, Reunion Island
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 = SIEMENS MEDICAL SOLUTIONS, USA, INC
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