Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.
- Recall Initiated
- October 14, 2011
- Posted
- November 23, 2011
- Terminated
- October 16, 2012
- Recall Number
- Z-0284-2012
- Quantity
- 3 units
- Firm Location
- Hoffman Estates, IL
Reason for Recall
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.
Distribution
Florida, Illinois and Texas
Lot / Code Info
Symbia T Series systems, serial numbers 12316, 1236 and 1013, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12
Root Cause
Component change control
Action Taken
Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated October 14, 2011 to all affected customers. The letters informed customers of the acquisition software defect in the energy window position when an isotope is peaked, which could potentially impact image interpretation, and that the AEB firmware version on their imaging system has been changed to a previously released version until acquisition software service pack is available. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at (800) 888-7436.