Philips Healthcare: Medical Device Recall in 2023 - (Recall #: Z-2520-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Incisive CT, software version 5.0

Product Classification:

Class II

Date Initiated: August 2, 2023

Date Posted: October 11, 2023

Recall Number: Z-2520-2023

Event ID: 93000

Reason for Recall:

Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.

Status: Ongoing

Product Quantity: 140 systems

Code Information:

software version 5.0

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated