FDA-Device2023-10-11Class II
Incisive CT, software version 5.0
Philips Healthcare
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
140 systems
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Incisive CT, software version 5.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2520-2023Don't want to check this manually?
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