The recall affects IMRIS Neuro III-SV models that use Siemens 3T magnets, citing a risk of blocked helium venting during a magnet quench.
IMRIS Imaging Inc is correcting IMRIS Neuro III-SV MRI models due to the possibility of an ice blockage in the helium venting pipe, according to a medical device recall early alert from the US Food and Drug Administration (FDA).Â
This recall is a downstream recall of the class I recall for the Siemens Healthineers 3 Tesla (3T) MRI systems. All impacted IMRIS MR units use the same 3T magnet and venting system from Siemens that are under recall. In the event of a sudden loss of superconductivity, or magnet quench, helium gas may be unable to escape through designated venting paths, leading to pressure build-up within the helium containment system.
This pressure buildup could rupture the helium containment system, potentially resulting in a massive helium leak into the scanning room, according to the FDA’s recall notice, which notes that “rupture of the helium containment system may also manifest as an explosion, with overpressure in the MRI room and debris expelled forcefully.”
This recall involves correcting devices. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if it’s continued to be used without correction. Â
IMRIS Neuro III-SV models impacted are:
- Neuro III-SV iMRI System
- iMRX System
- iMRI 3T S
- IMRIS iMRI 3T V
- InVision 3T Operating Suite
The recall notice notes that the issue can only be identified by qualified personnel from Siemens Healthineers service organization. Siemens Healthineers is preparing an inspection and, if necessary, a correction that will resolve this potential issue, according to the FDA’s recall notice .
The IMRIS Neuro III-SV is a traditional MRI unit that has been suspended on an overhead rail system and is designed to operate inside an RF-shielded room to facilitate intra-operative and multi-room use. The IMRIS operating suites incorporate Siemens 3T magnet. The magnet is normally situated in a diagnostic room until imaging is requested. The system retains all standard diagnostic features of an MRI system in the diagnostic room. The room is separated from the intra-operative operating room by sliding doors that are part of the facility structure.
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