Philips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk

Plain-English summary

Philips North America is recalling 15 units of the Philips Upgrade to MR 7700 with MR Elastography (Model 782130) distributed worldwide. The device can produce stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. This causes the reconstruction voxel size settings in the default MRE scan protocol to display incorrectly—too small—which could affect the accuracy of diagnostic results.

The recall affects installations in the United States and numerous international locations including Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Federation, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and the United Kingdom.

Patients and healthcare providers should contact Philips North America for instructions regarding affected systems. Specific serial numbers and UDI codes have been identified for the affected units.

The recalled product

Product

Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

Manufacturer

Philips North America

Category

Medical Device — MRI / Diagnostic Imaging Equipment

Hazard

• measurement-error
• image-reconstruction-error

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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