Recall Z-1677-2009 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
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
| Date | Aug 4, 2009 (initiated Apr 22, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Finished device change control |
| Action | 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 ques |
| Quantity | 38 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041166 | SIEMENS ENHANCED IMAGING SYSTEM Siemens Medical Solutions USA, Inc., May 17, 2004 |