Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems recall
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Why was Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems recalled?
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
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?
A) Symbia Intevo Bold system; Model Number 11007962; Serial Numbers: 1) 1499 (UDI:40568690011591499) 2) 1501(UDI: 40568690011591501) 3) 1505 (UDI: 40568690011591505) 4) 1510 (UDI: 40568690011591510) B) Symbia Intevo 6 system; Model Number 10764803; Serial Numbers: 1) 2352 (UDI: 40568690012342352) 2) 2353 (UDI: 40568690012342353) 3) 2354 (UDI: 40568690012342354)
- Product
- Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 7 devices
- Distribution
- Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)