FDA Device recall Z-1959-2026
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079,…
- 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 CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079,… 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-1959-2026 |
| 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 CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, 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): 781271. UDI: (01)00884838068452(21)78017, (01)00884838068452(21)78013, (01)00884838068452(21)780…1. Model Number (REF): 781271. UDI: (01)00884838068452(21)78017, (01)00884838068452(21)78013, (01)00884838068452(21)78014, (01)00884838068452(21)78034, (01)00884838068452(21)78058, (01)00884838068452(21)78073, (01)00884838068452(21)78075, (01)00884838068452(21)78092, (01)00884838068452(21)78112, (01)00884838068452(21)78123, (01)00884838068452(21)78201, (01)00884838068452(21)78202, (01)00884838068452(21)78215, (01)00884838068452(21)78217, (01)00884838068452(21)78239, (01)00884838068452(21)78247, (01)00884838068452(21)78260,(01)00884838068452(21)78286, (01)00884838068452(21)78287, (01)00884838068452(21)78026. Serial Numbers: 78017, 78013, 78014, 78034, 78058, 78073, 78075, 78092, 78112, 78123, 78201, 78202, 78215, 78217, 78239, 78247, 78260, 78286, 78287, 78026. 2. Model Number (REF): 782105. UDI: (01)00884838098312(21)78532, (01)00884838098312(21)78576. Serial Numbers: 78532, 78576. |
|---|
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-1959-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.