Philips BrightView MRI Systems Recalled for Unintended Movement

Plain-English summary

Philips Medical Systems (Cleveland) Inc. is recalling 1,064 units of BrightView, BrightView X, and BrightView XCT magnetic resonance imaging (MRI) systems. The affected models include the BrightView (model 882478), BrightView X (model 882480), and BrightView XCT (models 882482 and 882454). These devices are used for medical imaging.

The recall is due to software issues that can cause unintended detector and gantry movement. The FDA has classified this as a Class II recall, indicating that the defect could cause temporary or medically reversible health consequences. The affected units were distributed nationwide in the United States and internationally to numerous countries, including Canada, Australia, China, Germany, and the United Kingdom.

Healthcare facilities and consumers should check the serial numbers of their devices against the list provided by the manufacturer to determine if they are affected. If a device is affected, users should contact Philips Medical Systems for instructions on how to resolve the software issue. No specific corrective action steps are detailed in the provided source text, but the recall is intended to address the software defect.

The recalled product

Product

BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging

Manufacturer

Philips Medical Systems (Cleveland) Inc

Category

Medical Device — MRI Systems

Hazard

• unintended-movement
• software-defect

Affected units

1,064

Is your product affected?

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

Distribution

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