—#158854

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K162337
Affected lot / code info: Serial Number: 2141, 2144

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60192-2061

Distribution

Distribution pattern: Worldwide Distribution to Malaysia, France, Japan, Reunion Island

Timeline

Recall initiated: 2017-11-07
Terminated: 2019-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158854. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.