Toshiba Recalls Celesteion PET/CT Systems Due to Data Loss Risk
Toshiba American Medical Systems is recalling one Celesteion PCA-9000A/2 PET/CT System in Nevada because a software defect may prevent raw data from being saved during specific scans.
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 hazard involves data loss rather than direct physical injury or death, fitting the criteria for a moderate severity recall where the risk is significant but not immediately life-threatening.
Plain-English summary
Toshiba American Medical Systems Inc is recalling one unit of the Celesteion PCA-9000A/2 PET/CT System, specifically the Model TSX-301 CI6A with system software V7.0 SPOO04J. The device was distributed to the state of Nevada.
The recall was initiated because a software problem was identified that may prevent acquired raw data from being saved if specific operations are performed in multi-phase helical scanning. This defect could result in the loss of diagnostic data.
No specific instructions for consumers are provided in the source text, but the recall is limited to the single unit identified in Nevada.
The recalled product
- Product
- Celesteion PCA-9000A/2 PET/CT System
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 1
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 (1)
- Model: TSX-301 CI6A with system software V7.0 SPOO04J
Distribution
Distributed in 1 state:
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