Celesteion PCA-9000A/2 PET/CT System recall: Software Issue
Celesteion PCA-9000A/2 PET/CT System
Why was Celesteion PCA-9000A/2 PET/CT System recalled?
It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.
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?
Model: TSX-301 CI6A with system software V7.0 SPOO04J
- Product
- Celesteion PCA-9000A/2 PET/CT System
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 1
- Distribution
- US Distribution to the state of Nevada.
- Recall date
- October 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)