Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717741
This recall has been terminated (originally issued February 23, 2007).
- Recall Initiated
- January 30, 2007
- Posted
- February 23, 2007
- Terminated
- November 30, 2007
- Recall Number
- Z-0548-2007
- Quantity
- 16 units
- Firm Location
- Hoffman Estates, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution --- including USA states of Alabama, California, Georgia, Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Texas, Virginia and countries of Australia, Bolivia, Canada, China, France, Germany, Hong Kong and Spain.
Lot / Code Info
All systems with pinhole collimators and e.soft software versions 5.5 or earlier: part number 08717741, serial numbers 01006, 01008, 01009, 01019, 01021, 01022, 01024, 01032, 01033, 01034, 01038, 01044, 01045, 01049, 01051, 01052
Root Cause
Other
Action Taken
Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 1/30/07 to all users of Symbia systems with a pinhole collimator and e.soft software versions 5.5 or earlier. The accounts were informed of the potential for a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. The customers were advised that a Siemens Customer Service Representative would be sent to their site to upgrade their system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done free of charge.