Toshiba Celesteion PET/CT Systems Recalled for Detector Performance Degradation
Toshiba American Medical Systems is recalling three Celesteion PET/CT systems due to potential degradation of detector performance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Toshiba American Medical Systems Inc is recalling three units of the Celesteion PET/CT system, identified by item codes PCA-9000A/2, 9000A/3B, and 9000A/2B. The affected units have serial numbers 3BA1572002, 3BA1562001, and 2881492002. These systems are designed to acquire CT, PET, and fusion images of the human body.
The recall is being conducted due to a potential degradation of detector performance. The affected units were distributed in the United States to Wisconsin and Nevada.
Healthcare facilities that have these specific units should contact Toshiba American Medical Systems for further instructions regarding the recall.
The recalled product
- Product
- Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 3
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)
- Serial No. 3BA1572002
- 3BA1562001
- 2881492002
Distribution
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