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
