Philips North America Llc Incisive CT Computed Tomography X-ray System Model: 728143 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 contact you to schedule the Field Actions. Both of the Field Actions FCO72800745 & FCO72800742 will be free of charge.