Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 12/15/11
Class ll:
PRODUCT
1) Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient’s anatomy. Symbia S Series systems, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12. Recall # Z-0283-2012;
2) Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.
Symbia T Series systems, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12. Recall # Z-0284-2012
REASON
Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems< p>
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, letter dated October 14, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
FL, IL, TX
