Company:Siemens Medical Solutions USA, Inc.,
Date of Enforcement Report:2/28/2007
Class:ll
PRODUCT
a) Symbia S Series SPECT (Single-Photon Emission Computed Tomography)
System with a Pinhole Collimator; part number 08717741, Recall # Z-0548-2007;
b) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography
and Computed Tomography) System with a Pinhole Collimator, Recall # Z-0549-2007
REASON
Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
CODE
a) All systems with pinhole collimators and e.soft software versions 5.5 or earlier:
Serial numbers 01006, 01008, 01009, 01019, 01021, 01022, 01024, 01032,
01033, 01034, 01038, 01044, 01045, 01049, 01051, 01052;
b) All systems with pinhole collimators and e.soft software versions 5.5 or earlier:
Serial numbers 01015, 01032, 01037, 01045, 01061, 01065, 01068, 01072, 01074,
01076, 01077
RECALLING FIRM/MANUFACTURER
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated January 30, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide and Internationally