FDA Device recall Z-1961-2026
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 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 Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 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-1961-2026 |
| 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 Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
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): 781356. UDI: (01)00884838090040(21)47056, (01)00884838090040(21)47272, (01)00884838090040(21)471…1. Model Number (REF): 781356. UDI: (01)00884838090040(21)47056, (01)00884838090040(21)47272, (01)00884838090040(21)47189, (01)00884838090040(21)47310, (01)00884838090040(21)47006, (01)00884838090040(21)47029, (01)00884838090040(21)47044, (01)00884838090040(21)47068, (01)00884838090040(21)47196, (01)00884838090040(21)47206, (01)00884838090040(21)47208, (01)00884838090040(21)47237, (01)00884838090040(21)47260, (01)00884838090040(21)47289, (01)00884838090040(21)47291, (01)00884838090040(21)47294, (01)00884838090040(21)47303, (01)00884838090040(21)47305, (01)00884838090040(21)47322, (01)00884838090040(21)47325, (01)00884838090040(21)47330, (01)00884838090040(21)47339, (01)00884838090040(21)47380, (01)00884838090040(21)47387. Serial Numbers: 47056, 47272, 47189, 47310, 47006, 47029, 47044, 47068, 47196, 47206, 47208, 47237, 47260, 47289, 47291, 47294, 47303, 47305, 47322, 47325, 47330, 47339, 47380, 47387. 2. Model Number (REF): 782109. UDI: (01)00884838098350(21)47869, (01)0088483809835 |
|---|
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-1961-2026%22
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