CLASS II Device recall · Reported 15 Jun 2016 · FDA Enforcement Report

Ingenuity Core128 Computed Tomography X-Ray System recalled

Philips Healthcare is recalling Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System, distributed in 29 states. The recall was initiated on 6 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware v. 4.13, 4.14 and 4.15.

Quantity recalledUS - 423

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-1718-2016
FDA event ID: 74149
Recalling firm: Philips Healthcare, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 6 Sep 2015
FDA classified: 6 Jun 2016
Reported: 15 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

6 Sep 2015	Recall initiated by company
6 Jun 2016	Classified by FDA	+274 days
15 Jun 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm

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

Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System

Where it was distributed

US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.

Alabama Arkansas Arizona California Colorado District of Columbia Florida Georgia Iowa Illinois Indiana Louisiana Massachusetts Maryland Minnesota Missouri Mississippi North Carolina Nevada New York

Questions about this recall

Is Ingenuity Core128 Computed Tomography X-Ray System recalled?

Yes. Philips Healthcare recalled Ingenuity Core128 Computed Tomography X-Ray System on 6 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-1718-2016.

Why was it recalled?

Which lots are affected?

Software v. 4.13, 4.14 and 4.15.

Where was it sold?

US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.

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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