FDA Device recall Z-1958-2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 78210…
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 78210… 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-1958-2026 |
| 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 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
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): 781342. UDI: (01)00884838055339(21)71693, (01)00884838055339(21)71581, (01)00884838055339(21)715…1. Model Number (REF): 781342. UDI: (01)00884838055339(21)71693, (01)00884838055339(21)71581, (01)00884838055339(21)71582, (01)00884838055339(21)71607, (01)00884838055339(21)85216, (01)00884838055339(21)71106, (01)00884838055339(21)71477, (01)00884838055339(21)71512, (01)00884838055339(21)71966, (01)00884838055339(21)71967, (01)00884838055339(21)85147, (01)00884838055339(21)85224, (01)00884838055339(21)85318, (01)00884838055339(21)71462, (01)00884838055339(21)71619, (01)00884838055339(21)85250, (01)00884838055339(21)71002, (01)00884838055339(21)71037, (01)00884838055339(21)71269, (01)00884838055339(21)71841, (01)00884838055339(21)71885, (01)00884838055339(21)71897, (01)00884838055339(21)85126, (01)00884838055339(21)85109, (01)00884838055339(21)71296, (01)00884838055339(21)71188, (01)00884838055339(21)71088, (01)00884838055339(21)71387, (01)00884838055339(21)71799, (01)00884838055339(21)71040, (01)00884838055339(21)71344, (01)00884838055339(21)71583, (01)00884838055339(21)71916, (01)008 |
|---|
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-1958-2026%22
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