Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical So
FDA device recall Z-0584-2010 · posted 2009-12-29 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.
- Action taken
- Siemens issued an Urgent Field Correction Recall letters dated November 18, 2009 and December 11, 2009 to the affected users of the Symbia S and Symbia T Systems, respectivley. The customers were advised of precautionary measures and that Siemens will replace the affected device. They also were advised that a Siemens Customer Service Representative would contact them within a few days to schedule a replacement of the device. For further information, contact Siemens Medical Solutions USA, Inc. at 1-800-888-7436 (USA).
- Root cause
- Process control
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 97 units
- Distribution
- Worldwide Distribution -- United States, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Finland, France, Germany, Hong Kong, India, Indonesia, Italy, Korea, Mexico, Netherlands, Norway, P
- Date initiated
- 2009-12-11
- Date posted
- 2009-12-29
- Date terminated
- 2012-08-27
- Location
- Hoffman Estates, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIEMENS ENHANCED IMAGING SYSTEM (K041166) | Siemens Medical Solutions USA, Inc. | 2004-05-17 |