Brilliance iCT recall
Brilliance iCT
Why was Brilliance iCT recalled?
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
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?
Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203
- Product
- Brilliance iCT
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 1-unit
- Distribution
- Product was not distributed in the US. Unit was distributed in Australia.
- Recall date
- February 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)