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Philips Healthcare recalls Incisive CT, software version 5.0
Recalled October 11, 2023 · FDA recall Z-2520-2023 · 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. · FDA Class II
Units
140 systems
Sold at
US Nationwide Distribution
Description
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.
Product
Incisive CT, software version 5.0
Manufacturer(s)
Philips Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →