Recall Z-1507-2024 ยท JAK System, X-Ray, Tomography, Computed
Philips North America
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
| Date | Apr 9, 2024 (initiated Dec 24, 2020) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Software design |
| Action | 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 |
| Quantity | 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 Indonesia Iraq Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Libya Malaysia M |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180015 | Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd., Mar 20, 2018 |