Ingenuity Core 128-Computed Tomography X-ray system recall: Software Issue
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system…
Why was Ingenuity Core 128-Computed Tomography X-ray system recalled?
Philips Healthcare received reports from the field that certain Ingenuity Core128 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 Core128:System Code #728323, Serial numbers: 320001, 320016, 320076, 320077, 320080, 320085, 320086, 320087, 320088, 320089, 320091, 320113, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336014
- Product
- Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 19
- 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)