FDA Device recall Z-1830-2024
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnost…
- FDA Device
- Class II
- ongoing
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class II recall of Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnost… 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-1830-2024 |
| 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 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
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)00884838099739(21) Serial Numbers: 42029 42217 42246 71044 71774 85146 85645 85663 85664 85668 85677 85680 85681 85685 85700 85704 85705 85706 85713 |
|---|
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-1830-2024%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.