Recall Z-1648-2009 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741.
| Date | Jul 7, 2009 (initiated Mar 11, 2009) |
| Status | Terminated |
| Reason | Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.e. the patient or pallet is into the field of view. |
| Root cause | Software design |
| Action | Siemens sent Urgent Field Correction Recall letters dated 1/20/09 to all users of the Symbia S and Symbia T Systems. The accounts were informed of the potential injury to patients while lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. The customers were advised to perform all necessary collimator changes before the patient is positioned on the patient bed, and to examine each of their workflows that include a Tomo Acquisition activity and make sure the Auto Collimator Change check box on the C |
| Quantity | 152 units |
| Distribution | Worldwide distribution, including USA, Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden 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 |