Philips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk
Philips is recalling 15 units of its MR 7700 with MR Elastography upgrade due to potential stiffness value errors in MRI scans when specific image reconstruction parameters are used with the Resoundant algorithm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text describes a technical parameter error with no reported illnesses or injuries, making it a moderate-severity issue that warrants correction but does not meet the threshold for High or above per the rubric.
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
- Affected units
- 15
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 (20)
- 1. Model Number (REF): 782130. UDI: (01)00884838104402(21)45052
- (01)00884838104402(21)42030
- (01)00884838104402(21)42151
- (01)00884838104402(21)71279
- (01)00884838104402(21)71565
- (01)00884838104402(21)42104
- (01)00884838104402(21)42163
- (01)00884838104402(21)42376
- (01)00884838104402(21)45179
- (01)00884838104402(21)45236
- (01)00884838104402(21)45263
- (01)00884838104402(21)71532
- (01)00884838104402(21)85394
- (01)00884838104402(21)85643
- (01)00884838104402(21)85644. Serial Numbers: 45052
- 42030
- 42151
- 71279
- 71565
- 42104
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Philips North America 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.
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