The Recall Desk
HighFDA (Devices)·Z-1415-2018·Announced 2018-04-25

Philips Brilliance 6 Slice CT System Recalled for Emergency Stop Defect

Philips is recalling Brilliance 6 Slice 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

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling the Brilliance 6 Slice (Air) Computed Tomography X-Ray system, Model no. 728256. The recall is due to a defect where closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

The affected units were distributed worldwide, including the United States, Canada, Mexico, and numerous international locations. The specific serial number identified in the recall is 30018.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address this issue. Patients and consumers should not use the device until it has been inspected or repaired by the manufacturer.

The recalled product

Product
Brilliance 6 Slice (Air) - Model no. 728256, 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. Th
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial no: 30018

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 →