Recall Z-0190-2009 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used to perform CT scans and nuclear imaging studies with the same instrument, obtaining attenuation corrected images and providing registration of anatomical and physiological images within the patient's a
| Date | Oct 27, 2008 (initiated Sep 29, 2008) |
| Status | Terminated |
| Reason | The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 9/29/08 to all users of the Symbia T6 and Symbia T16 Systems. The accounts were informed of the potential risk that the protective plastic cap over the CT gantry power switch could come loose, causing an electrical hazard. The customers were advised to avoid contact with the gantry power switch until the protective plastic cap has been replaced, and to leave the power switch on at the line connection box and cycle the CT gantry on and off by toggling the CT gantry circuit breaker within the circuit box. |
| Quantity | 10 units |
| Distribution | Nationwide to the District of Columbia, Florida, Georgia, Illinois, Indiana, Missouri, Ohio, and Texas, and internationally to Australia, Brazil, Canada, Great Britain, India, Italy, Japan, Norway and Switzerland. |
| 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 |