FDAFDA · Food and drugs·Recall number Z-2520-2023
Incisive CT, software version 5.0
Published October 11, 2023 · Recall initiated: August 2, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Philips Healthcare
- Distributor
- US Nationwide Distribution
- Lot
- software version 5.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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