Ingenuity Core-Computed Tomography X-ray system Product recall: Software Issue
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to…
Why was Ingenuity Core-Computed Tomography X-ray system Product recalled?
Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
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?
Ingenuity Core,System Code #728321, Serial numbers: 310101, 310102, 310103, 310104, 310105, 310106, 310108, 310109, 310112, 310115, 310137, 333006, 333008, 333011, 333012, 333013, 333016, 333017, 333023
- Product
- Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 18
- Distribution
- US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
- Recall date
- July 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)