Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-2118-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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..

Product Classification:

Class II

Date Initiated: April 1, 2016

Date Posted: July 6, 2016

Recall Number: Z-2118-2016

Event ID: 74427

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.

Status: Terminated

Product Quantity: 19

Code Information:

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

Distribution Pattern:

US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX

Voluntary or Mandated:

Voluntary: Firm initiated