CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
Ingenuity Core 128-Computed Tomography X-ray system recalled
Philips Medical Systems (Cleveland) is recalling Ingenuity Core 128-Computed Tomography X-ray system, distributed nationwide in the US. The recall was initiated on 1 Apr 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2118-2016
- FDA event ID
- 74427
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2016
- FDA classified
- 30 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 1 Apr 2016 | Recall initiated by company | |
| 30 Jun 2016 | Classified by FDA | +90 days |
| 6 Jul 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The 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..
Where it was distributed
US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
Nationwide CaliforniaFloridaIdahoKansasMichiganNew YorkOhioTexas
Questions about this recall
Is Ingenuity Core 128-Computed Tomography X-ray system recalled?
Yes. Philips Medical Systems (Cleveland) recalled Ingenuity Core 128-Computed Tomography X-ray system on 1 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-2118-2016.
Why was it 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.
Which lots 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
Where was it sold?
US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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