MRI System Recall: Potential Helium Leak Risk from Magnet Venting Blockage
The MAGNETOM Connectom.X MRI system is being recalled due to potential ice blockages in the magnet venting system. If a blockage prevents helium from venting during operation, system rupture and helium leak into the scanning room could occur.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: Agency classification as FDA Class I medical device recall establishes minimum severity of Severe per rubric. Potential system rupture and helium release represents serious hazard despite no reported injuries to date.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the MAGNETOM Connectom.X magnetic resonance imaging system (Model 11371480) due to a potential ice blockage hazard in the magnet venting system.
The venting system is designed to safely release helium gas from the magnet during normal operation and emergency quench events. If ice blockage forms or exists within the venting system, helium gas may be unable to escape through the designed venting paths. This would result in pressure buildup within the helium containment system, potentially causing the containment to rupture and release helium into the scanning room.
The recalled system has been distributed worldwide, including throughout the United States and in numerous countries. The FDA has classified this as a Class I recall.
The recalled product
- Product
- MAGNETOM Connectom.X. Model Number: 11371480.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- ice-blockage
- venting-failure
- pressure-buildup
- system-rupture
- helium-leak
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 11371480. UDI Numbers: N/A. Serial Numbers: 237551.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03