Philips CT Systems Recalled for Potential Patient Support Movement

Plain-English summary

Philips Medical Systems (Cleveland) Inc. is recalling 126 units of Brilliance 6, 10, 16, 40, 64, and CT Big Bore Computed Tomography X-Ray Systems. The recall is due to a potential safety hazard where the patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.

The affected devices are distributed worldwide, including in the United States and various international markets. The recall includes specific system codes and serial numbers, which are detailed in the official FDA recall notice. No illnesses or injuries have been reported in connection with this recall.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the issue. Consumers and patients should consult their healthcare provider if they have concerns about their recent CT scans.

The recalled product

Product

The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bo

Manufacturer

Philips Medical Systems (Cleveland) Inc

Category

Medical Device — Imaging Equipment

Hazard

• unintended-movement

Affected units

126

Is your product affected?

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

Distribution

Related recalls