Recall – Potential for radionuclide detection system to lose time information

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 9/2/2020
Class II

PRODUCT

E.cam or Symbia systems that use foresight detectors – Product Usage: 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.

Recall Number: Z-2898-2020

REASON

E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurrence is remote. 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.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 3/31/2016. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

5,066 systems

DISTRIBUTION

U.S. Nationwide

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course sponsored by the Irish Medtech Association / Ibec, Connected Health Skillnet.  November 19, 2020, 9 am to 6 pm IST.  Read more and registration information:  Agile methods Flyer (19 Nov)

Registration Link:  https://connectedhealthskillnet.ie/IBEC/Events.nsf/

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Tampa, FL 33624
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+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.