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Open, Classified

Incisive CT, software version 5.0

FDA Recall Z-2520-2023 · Posted 2023-09-30

Recalling FirmPhilips Healthcare
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2023-08-02
Product Quantity140 systems

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.

Firm Action

Philips will inform customers of the issue via an Electronic Product Radiation Defect notification. Philips will schedule an appointment with customers to install the software update.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2022-04-27K211168Philips Incisive CT on TrailerPhilips Healthcare (Suzhou) Co., Ltd. · 2021-11-22K180015Philips 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.

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