FDA Device recall Z-1969-2026
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130 by Philips North America, citing the potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1969-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-14 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Reason
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Identifiers
| code_info | 1. Model Number (REF): 782130. UDI: (01)00884838104402(21)45052, (01)00884838104402(21)42030, (01)00884838104402(21)421…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, 42163, 42376, 45179, 45236, 45263, 71532, 85394, 85643, 85644. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1969-2026%22
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