Reported Jul 6, 2016 · Terminated
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Ingenuity Core 128-Computed
- Tomography X-ray system Product UsageThe Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
- Lot codes and dates
- Ingenuity Core128System Code #728323
- Serial numbers
320001320016320076320077320080320085320086320087320088320089320091320113336001336002336003336006336007336008336009336010336014
- Amount recalled
- 19
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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