Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans an
FDA device recall Z-0960-2015 · posted 2015-01-13 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.
- Action taken
- The firm, Siemens, sent an undated "Customer Safety Advisory Notice" letter to all customers. The described the product, problem and actions to be taken. The letters inlcuded instructions for customers to: 1) continue to use their systems while waiting for the field correction to be scheduled and performed; 2) ensure that the safety advisory is placed in the system's instruction for use; and, 3) closely observe the patient during studies. The letter also instructs customers of record to forward a copy of the letter to the new owner if the equipment was sold or transferred. Customers with any questions about this issue can contact Siemens Molecular Imaging at 800-888-7436 (US).
- Root cause
- Component change control
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 295 systems
- Distribution
- Worldwide Distribution: US Nationwide including Puerto Rico; Austria, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, Finland
- Date initiated
- 2014-03-05
- Date posted
- 2015-01-13
- Date terminated
- 2016-12-23
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMBIA, VERSION 4.0 (K082506) | Siemens Medical Solutions USA, Inc. | 2008-11-21 |