SPECT/CT Imaging Systems Recalled Due to Defective Balancing Weight Bolts
Siemens is recalling seven Symbia Intevo SPECT/CT imaging systems due to a quality defect in the bolts that secure the CT balancing weights, which could create a safety issue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a structural defect in diagnostic imaging equipment that could create a safety issue. No illnesses or injuries have been reported. Classified as High because it involves a mechanical defect in a risk-of-harm medical device without documented patient harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling seven Symbia Intevo imaging systems due to a quality defect. The affected systems are Symbia Intevo Bold and Symbia Intevo 6 models that were distributed outside the United States.
The defect involves the three bolts that hold the CT balancing weights. This quality issue could create a safety issue with the device.
These systems were distributed to medical facilities in El Salvador, France, Germany, Japan, Taiwan, and the United Kingdom.
The recalled product
- Product
- Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- A) Symbia Intevo Bold system
- Model Number 11007962
- Model Number 10764803
Distribution
Distribution scope not specified by the agency.
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