FDA Device recall Z-1933-2025
Intera 1.5T Master/Nova Product Number: 781106
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Intera 1.5T Master/Nova Product Number: 781106 by Philips North America, citing identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1933-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-29 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Intera 1.5T Master/Nova Product Number: 781106;
Reason
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Identifiers
| code_info | Product Number: 781106; UDI-DI: no UDI; Serial Numbers: 8009, 18863; |
|---|
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-1933-2025%22
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