Recall Z-2520-2023— Philips Healthcare
Class II · Ongoing
Class II FDA medical device recall by Philips Healthcare, initiated 2023-08-02. It names 3 FDA 510(k) clearances: K212441, K211168, K180015. Product: Incisive CT, software version 5.0. Reason: 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..
- Recalling firm
- Philips Healthcare
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-02
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
3 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.