Siemens MAGNETOM Spectra MRI system recall for ice blockage
Siemens Medical Solutions is recalling 3 MAGNETOM Spectra MRI systems worldwide due to a potential ice blockage in the magnet venting system that could prevent helium gas from escaping and cause pressure buildup.
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: FDA Class I designation requires minimum severity score of 4 per recall rubric. While no reported injuries or deaths exist, the potential for helium system rupture and cryogenic gas release in a clinical environment constitutes a serious hazard.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 3 MAGNETOM Spectra magnetic resonance imaging (MRI) systems. The affected units were distributed worldwide, including throughout the United States and to more than 100 countries.
The recalled systems contain a potential ice blockage in the magnet venting system. During a quench event (emergency helium release), this blockage could prevent helium gas from escaping through the designed venting paths. This could lead to pressure buildup within the helium containment system, which may rupture and cause a helium leak into the scanning room.
Healthcare facilities operating these systems should immediately contact Siemens Medical Solutions for guidance. A helium leak into the scanning room poses a risk to personnel and device integrity. The affected units have the following model and serial numbers: Model 10837643 (Serial 72030, 72023) and Model 10655588 (Serial 56069).
The recalled product
- Product
- MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device
- Hazard
- ice-blockage
- pressure-buildup
- helium-leak
Distribution
Distributed nationwide across the United States.
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