Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728
FDA device recall Z-1872-2024 · posted 2024-05-20 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
- Action taken
- Philips issued URGENT Medical Device Correction Letter on 4/15/24 to US consignees. [International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements]. Letter states reason for recall, health risk and action to take: " Please continue to use your system in accordance with its intended use. If you need to remain in the room for the duration of a scan, Philips recommends using protective eyewear. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. " Place this URGENT Medical Device Correction Letter with your system documentation. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken . Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a solution to address the issue (reference FCO72800819 and FCO72800820). If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 155 units
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2024-04-15
- Date posted
- 2024-05-20
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Philips Incisive CT (K212441) | Philips Healthcare (Suzhou) Co., Ltd. | 2022-04-27 |