MR 7700 upgrades recalled over elastography stiffness value errors
Philips North America is recalling 6 units of the Upgrade to MR 7700 because exported MR Elastography stiffness maps may show stiffness value errors.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states exported elastography maps may show incorrect stiffness values, and no injuries are reported.
Plain-English summary
The Philips Upgrade to MR 7700, product code 782130, covering MR systems with software versions R11.1 and R12.1, is being recalled by Philips North America.
The reason given in the enforcement record is the potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps in a viewer Picture Archiving and Communication System (PACS).
The record lists 6 units, with UDI-DI codes and serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
An incorrect stiffness value is a measurement a clinician reads. The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI
- Affected units
- 6
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 (5)
- 85644
- 42163
- 42151
- 45236
- 85643.
Distribution
Part of a larger recall action
This product is one of 13 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.
See all 13 products in this recall →Related recalls
Same manufacturer · Philips North America
See all →- ModeratePhilips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
Same hazard · measurement error
See all →- ModeratePhilips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk
FDA (Devices) · 2026-05-06
- ModeratePhilips Ingenia Ambition X MRI Systems Stiffness Value Error Recall
FDA (Devices) · 2026-05-06
- ModeratePhilips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors
FDA (Devices) · 2026-05-06
- HighPhilips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
FDA (Devices) · 2026-05-06
- ModeratePhilips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
FDA (Devices) · 2026-05-06
Similar recalls
- ModeratePhilips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk
FDA (Devices) · 2026-05-06
- SevereMR 7700 systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- ModeratePhilips MR 7700 MR Elastography device stiffness value error recall
FDA (Devices) · 2026-05-06
- HighIngenia 3.0T systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- HighPhilips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
FDA (Devices) · 2026-05-06
- ModeratePhilips Evolution 3.0T MR Elastography upgrade stiffness calculation error
FDA (Devices) · 2026-05-06