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.
This recall has been terminated (originally issued August 4, 2009).
- 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
- Official Source
- View on FDA website ↗
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.