PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intende
FDA device recall Z-1507-2024 · posted 2024-04-09 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- Reason for recall
- Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
- Action taken
- Philips Healthcare issued Customer Information letter on 12/24/20 via USPS. Letter states reason for recall, health risk and action to take: You may continue to use your system(s) in accordance with the intended use. Refer to ADVICE ACTIONS BY CUSTOMER/USER of the customer letter for specific details regarding the issue descriptions and advice to customers. Should the customer feel uncertain regarding this action, please contact your local Philips representative. Field Change Orders (FCO72800727) involving software upgrade will be released to correct the issue at no charge to you. The planned release date is in Q1 2021. A Philips Field Service Engineer will contact you to schedule the upgrade at your site.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 428 units
- Distribution
- Nationwide including Puerto Rico Foreign: Albania Argentina Australia Austria Bangladesh Bolivia Brazil Bulgaria China Czech Republic Denmark Ecuador Egypt France Germany Greece Hungary India Indonesi
- Date initiated
- 2020-12-24
- Date posted
- 2024-04-09
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Philips Incisive CT (K180015) | Philips Healthcare (Suzhou) Co., Ltd. | 2018-03-20 |