29
Sep
2023

FDA Recall: Three Software Compliance Concerns

,
0

Company: Philips Healthcare
Date of Enforcement Report: 09/29/2023
Class II

PRODUCT

Incisive CT, software version 5.0

Recall Number:

Z-2520-2023

REASON:

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

RECALLING FIRM/MANUFACTURER:

Philips Healthcare

VOLUME OF PRODUCT IN COMMERCE:

137 systems

DISTRIBUTION:

US Nationwide Distribution

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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