Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part numb
FDA device recall Z-1648-2009 · posted 2009-07-07 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- 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.
- Action taken
- 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 Camera Parameters Tab is not checked. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a corrective software upgrade 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 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, P
- Date initiated
- 2009-03-11
- Date posted
- 2009-07-07
- Date terminated
- 2010-09-11
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIEMENS ENHANCED IMAGING SYSTEM (K041166) | Siemens Medical Solutions USA, Inc. | 2004-05-17 |