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Philips Healthcare
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Philips Healthcare and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-10-11FDA-DeviceClass IIIncisive CT, software version 5.0
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.
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