FDA Device recall Z-1962-2026
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF):…
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF):… 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-1962-2026 |
| 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 Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
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): 781357. UDI: (01)00884838088108(21)46002. Serial Numbers: 46002. 2. Model Number (REF): 782106…1. Model Number (REF): 781357. UDI: (01)00884838088108(21)46002. Serial Numbers: 46002. 2. Model Number (REF): 782106. UDI: (01)00884838098329(21)46243, (01)00884838098329(21)46292, (01)00884838098329(21)46317. Serial Numbers: 46243, 46292, 46317. 3. Model Number (REF): 782137. UDI: (01)00884838108615(21)64034, (01)00884838108615(21)64045. Serial Numbers: 64034, 64045. |
|---|
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-1962-2026%22
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