Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-2117-2016)

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-Computed Tomography X-ray system Product Usage: The Ingenuity Core 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-2117-2016

Event ID: 74427

Reason for Recall:

Philips Healthcare received reports from the field that certain Ingenuity Core 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: 18

Code Information:

Ingenuity Core,System Code #728321, Serial numbers: 310101, 310102, 310103, 310104, 310105, 310106, 310108, 310109, 310112, 310115, 310137, 333006, 333008, 333011, 333012, 333013, 333016, 333017, 333023

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated