FDA Device recall Z-1829-2024
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic…
- FDA Device
- Class II
- ongoing
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class II recall of Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic… by Philips North America, citing philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1829-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-22 |
| Published | 2024-05-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
Reason
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Identifiers
| code_info | UDI-DI: (01)00884838099722(21) Serial Numbers: 41017 41024 41025 41041 41047 41051 41080 41089 41130 41143 41144 41189…UDI-DI: (01)00884838099722(21) Serial Numbers: 41017 41024 41025 41041 41047 41051 41080 41089 41130 41143 41144 41189 41196 41226 41235 41286 41287 41344 41367 41413 41432 41433 41497 41520 70093 70099 70202 70260 70589 70996 81073 84370 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1829-2024%22
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