Philips Healthcare Recall 93000
Description: Incisive CT, software version 5.0
Philips Healthcare Recall 93000 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-2520-2023 |
| Event ID | 93000 |
| Event Description | Incisive CT, software version 5.0 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 140 systems |
| Recall 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. |
| Device Classification | 20231011 |
| Device Code Info | software version 5.0 |
| Center Classification Date | 20230929 |
| Recall Initiation Date | 20230802 |
| Recalling Firm | Philips Healthcare |
| Initial Notification | Letter |
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