Recall Z-1265-2021 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Incisive CT Computed Tomography X-ray System Model: 728143
| Date | Feb 22, 2021 |
| Status | Terminated |
| Reason | Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees |
| Root cause | Process control |
| Action | Philips notified US consignee on 2/22/2021via email including the Field Safety Notice informing of the reason for recall, health risk and action to take: stop using the system until a Philips Field Service engineer arrives on site to implement the correction to lock the gantry tilt function (FCO72800745). After the FCO72800745 implementation, the device can continue to operate without tilt function until the final correction (FCO72800742) is implemented to replace the nonconforming actuators which will remedy the issue and return device to normal use. A Philips Service Engineer will cont |
| Quantity | 105 units (1 US and 104 OUS) |
| Distribution | US Virgin Island Foreign: Australia Bolivia China Germany Hungary Indonesia Italy Japan Korea Korea, Republic of Latvia Palestine Philippines Romania Russian Federation Senegal Thailand Uzbekistan |
| 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 |