The Recall Desk
SevereFDA (Devices)·Z-1409-2018·Announced 2018-04-25

Philips Brilliance iCT SP CT Systems Recalled for Emergency Stop Defect

Philips is recalling 19 Brilliance iCT SP CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect that poses a significant risk of injury to patients during loading and unloading, meeting the criteria for a Severe rating.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 19 units of the Brilliance iCT SP Computed Tomography X-Ray system (Model no. 728311). The recall is due to a defect where closing the Emergency Stop may disable the horizontal motor. This malfunction allows the couch top to move during patient load or unload activities.

The affected units were distributed worldwide, including in the United States, Canada, Mexico, and numerous other countries. Specific serial numbers for the affected units are listed in the recall documentation.

Healthcare facilities should contact Philips Medical Systems to arrange for the necessary corrective actions to address the emergency stop functionality and ensure patient safety during patient positioning.

The recalled product

Product
Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devi
Affected units
19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →