Brilliance iCT Computed Tomography X-ray system recall
Brilliance iCT Computed Tomography X-ray system
Why was Brilliance iCT Computed Tomography X-ray system recalled?
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
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# 728306; Serial #'s: 85019 & 85023.
- Product
- Brilliance iCT Computed Tomography X-ray system
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 2
- Distribution
- Internationally to the countries of China and Norway.
- Recall date
- June 10, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)