The Symbia Intevo Excel is a non-diagnostic SPECT ICT recall
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia…
Why was The Symbia Intevo Excel is a non-diagnostic SPECT ICT recalled?
Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) Symbia Intevo 6: Product Number: 10764803; Serial Numbers: 1001 ; 1002 ; 2) Symbia Intevo 16; Product Number: 10764804; Serial Numbers: 1001 ; 1002 ; 3) Symbia Intevo Excel; Product Number: 10764801; Serial Numbers: 1001 ; 1002
- Product
- The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia…
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 6 systems
- Distribution
- Worldwide Distribution - USA (naitonwide) and Internationally to Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
- Recall date
- January 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)