Recall Z-2898-2020— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-2898-2020
Creator: U.S. Food and Drug Administration
Published: 2016-03-31

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2016-03-31, terminated 2020-10-29. It names one FDA 510(k) clearance: K142006. 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.. 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: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-31
Terminated: 2020-10-29
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K142006 — SYMBIA 6.0Siemens Medical Solutions USA, Inc.·cleared 2014-08-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.