FDA recall Z-2520-2023

Product

Incisive CT, software version 5.0

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.

Distribution

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2023-08-02

Report date

2023-10-11

Voluntary/Mandated

FDA Mandated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2520-2023