Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
FDA Recall Z-0960-2015 · Posted 2015-01-13
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2014-03-05
Date Terminated2016-12-23
Product Quantity295 systems
Reason for Recall
There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system.
components.
Firm Action
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
Distribution Pattern
Worldwide Distribution: US Nationwide including Puerto Rico; Austria, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hungary, Ireland, India, Iran, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Tunisia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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