Open, Classified

PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143

FDA Recall Z-1507-2024 · Posted 2024-04-09

Recall StatusOpen, Classified

Product CodeJAK

Date Initiated2020-12-24

Product Quantity428 units

Reason for Recall

Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured

Firm Action

Philips Healthcare issued Customer Information letter on 12/24/20 via USPS. Letter states reason for recall, health risk and action to take: You may continue to use your system(s) in accordance with the intended use. Refer to ADVICE ACTIONS BY CUSTOMER/USER of the customer letter for specific details regarding the issue descriptions and advice to customers. Should the customer feel uncertain regarding this action, please contact your local Philips representative. Field Change Orders (FCO72800727) involving software upgrade will be released to correct the issue at no charge to you. The planned release date is in Q1 2021. A Philips Field Service Engineer will contact you to schedule the upgrade at your site.

Root Cause

Software design

Distribution Pattern

Nationwide including Puerto Rico Foreign: Albania Argentina Australia Austria Bangladesh Bolivia Brazil Bulgaria China Czech Republic Denmark Ecuador Egypt France Germany Greece Hungary India Indonesia Iraq Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Libya Malaysia Myanmar Nepal Netherlands Norway Pakistan Palestine, State of Peru Philippines Poland Puerto Rico Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Spain Sweden Switzerland Thailand Tunisia Turkey United Arab Emirates United Kingdom Uzbekistan Viet Nam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180015Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2018-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.