Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 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.
- Recall Initiated
- April 22, 2009
- Posted
- August 4, 2009
- Terminated
- June 21, 2010
- Recall Number
- Z-1677-2009
- Quantity
- 38 units
- Firm Location
- Hoffman Estates, IL
Reason for Recall
The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.
Distribution
Worldwide Distribution -- USA, Australia, Austria, Brazil, Bulgaria, Canada, China, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Russia, Spain, Taiwan, and Turkey.
Lot / Code Info
part 10275007, serial numbers 1043, 1044, 1048, 1049, 1050, 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058; part 10275008, serial numbers 1044, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1064, 1065; part 10275009, serial numbers 1037, 1038, 1039, 1040, 1041, 1042, 1044, 1045; part 10275010, serial numbers 1009, 1010, 1011, and 1012.
Root Cause
Finished device change control
Action Taken
Siemens sent Urgent Field Correction Recall letters dated 4/22/09 to the affected users of the Symbia S and Symbia T Systems. The accounts were informed of the potential faulty pinion gear which could crack and cause the gantry to spin freely, damaging the system and potentially injuring a patient during a scan. The customers were advised to stop using the system if they hear any abnormal grinding noise from the gantry. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a replacement of the pinion gear free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.