FDA Device recall Z-1964-2026
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153 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-1964-2026 |
| 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 MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
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): 782120. UDI: (01)00884838104112(21)65019, (01)00884838104112(21)65004, (01)00884838104112(21)650…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, 65065, 65038, 65005, 65043, 65049, 65051, 65060. 2. Model Number (REF): 782153. UDI: (01)00884838112858(21)68034, (01)00884838112858(21)68042, (01)00884838112858(21)68014, (01)00884838112858(21)68001, (01)00884838112858(21)68007, (01)00884838112858(21)68008, (01)00884838112858(21)68017, (01)00884838112858(21)68025, (01)00884838112858(21)68037, (01)00884838112858(21)68041, (01)00884838112858(21)68019. Serial Numbers: 68034, 68042, 68014, 68001, 68007, 68008, 68017, 68025, 68037, 68041, 6 |
|---|
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-1964-2026%22
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