Philips Healthcare: Medical Device Recall in 2016 - (Recall #: Z-1719-2016)

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:

Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System

Product Classification:

Class II

Date Initiated: September 6, 2015

Date Posted: June 15, 2016

Recall Number: Z-1719-2016

Event ID: 74149

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

Status: Terminated

Product Quantity: US - 423

Code Information:

Software v. 4.13, 4.14 and 4.15.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated