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System Correction: IMPRIS Imaging Inc Issues Correction for IMRIS Neuro III-SV

IMPRIS Imaging Inc is correcting IMRIS Neuro III-SV models due to the possibility of an ice blockage in the helium venting pipe.

This recall is a downstream recall of the class I recall for the Siemens Healthineers 3 Tesla MRI systems. All impacted IMPRIS MR units uses 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 build up could rupture the helium containment system, potentially resulting in a massive helium leak into the scanning room. 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 and does not involve removing them from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Questions?

Customers in the U.S. with questions about this recall should contact IMPRIS Imaging Inc customer support team at 1-866-475-0525 or customersupport@imris.com