Philips MR 7700 MR Elastography device stiffness value error recall
Philips is recalling certain MR 7700 devices with MR Elastography due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause voxel size settings to display incorrectly.
What this means for you
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 indicates a potential for measurement or display errors under specific parameter conditions, but does not report any actual injuries, hospitalizations, or deaths. No illnesses or adverse health outcomes are stated.
Plain-English summary
Philips North America is recalling certain Philips MR 7700 devices equipped with MR Elastography (MRE). The affected units are Model Number 782120 and Model Number 782153, distributed worldwide including throughout the United States.
The recall is prompted by a potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. This combination can cause the reconstruction voxel size settings in the default MRE scan protocol to display too small.
Users of affected devices should contact Philips North America for instructions on how to address this issue. Specific guidance on remediation steps should be obtained from the manufacturer.
The recalled product
- Product
- Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
- Manufacturer
- Philips North America
- Affected units
- 25
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): 782120. UDI: (01)00884838104112(21)65019
- (01)00884838104112(21)65004
- (01)00884838104112(21)65028
- (01)00884838104112(21)65031
- (01)00884838104112(21)65039
- (01)00884838104112(21)65056
- (01)00884838104112(21)65066
- (01)00884838104112(21)65065
- (01)00884838104112(21)65038
- (01)00884838104112(21)65005
- (01)00884838104112(21)65043
- (01)00884838104112(21)65049
- (01)00884838104112(21)65051
- (01)00884838104112(21)65060. Serial Numbers: 65019
- 65004
- 65028
- 65031
- 65039
- 65056
- 65066
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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