Brilliance iCT Product Usage: Computed Tomography X-ray recall
Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of…
Why was Brilliance iCT Product Usage: Computed Tomography X-ray recalled?
Failure to correctly document the installation of four M12 Bolts into the system rotor.
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 Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
- Product
- Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 1
- Distribution
- The one system was distributed in Canada. There were no government or US distribution.
- Recall date
- January 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)