Incisive CT, software version 5.0
Reported: October 11, 2023 Initiated: August 2, 2023 #Z-2520-2023
Product Description
Incisive CT, software version 5.0
Reason for Recall
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.
Details
- Recalling Firm
- Philips Healthcare
- Units Affected
- 140 systems
- Distribution
- US Nationwide Distribution
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Incisive CT, software version 5.0. Recalled by Philips Healthcare. Units affected: 140 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2520-2023.
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