Medical imaging device faces potential helium leak during emergency shutdown
A BIOGRAPH One medical imaging device may develop ice blockage in its helium venting system. During an emergency magnet shutdown, this could prevent proper gas escape and cause helium to leak into the scanning room.
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: This is an FDA Class I medical device recall. FDA Class I classification mandates a minimum severity of 4 per the rubric. The hazard involves potential system rupture and helium release into an occupied medical facility, representing serious potential harm.
Plain-English summary
Siemens Medical Solutions is recalling the BIOGRAPH One (DE) medical imaging device (Model 11689172, Serial Number 238008) due to a potential ice blockage in the helium venting system.
During an emergency magnet shutdown (quench), helium gas is designed to escape through venting paths to safely relieve internal pressure. An ice blockage could prevent this venting, causing pressure to build up inside the helium containment system. This pressure build-up could rupture the containment system and result in helium leaking into the scanning room.
The affected device has been distributed worldwide including in the United States and numerous international locations.
The recalled product
- Product
- BIOGRAPH One (DE). Model Number: 11689172.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- helium-leak
- pressure-rupture
- ice-blockage
Distribution
Distributed nationwide across the United States.
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