Explosion risk in Philips’ MRI scanners leads to FDA Class I recall

In additional recall woes for Philips, 150 of its magnetic resonance imaging (MRI) scanners have been recalled because of being vulnerable to exploding.

In contrast to lots of Philips’ previous recalls centred round its respiratory gadget product line, the corporate despatched out an pressing medical gadget correction to customers of its Panorama 1.0T open MRI system after it discovered that the machines are vulnerable to extreme strain build-up of helium gasoline.

The US Meals and Drug Administration (FDA) tagged this recall as Class I – probably the most critical sort of recall indicating that continued use of the units might trigger critical accidents or demise.

In keeping with an FDA alert on 20 December, the chance of explosion is throughout a quench – a process used to quickly expel liquid cryogen to keep up the superconductivity of the MRI magnet. Equally, unintended quenches can even happen. The extreme construct of strain in both situation might compromise the structural integrity of the gadget, the FDA stated.

Sufferers could possibly be uncovered to chemical compounds and lack of oxygen within the occasion of an explosion, in addition to traumatic accidents from the explosion itself. The FDA highlights tissue injury and mechanical trauma attributable to particles – together with the potential for mind harm and even demise.

The FDA acknowledged there was one reported explosion in the course of the system’s 22 years of use and no accidents or deaths up to now.

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Clients have been advised to discontinue utilizing the scanners. Philips additionally urged customers to not carry out a handbook quench of the magnet apart from emergency use.

The FDA highlighted the recall was a correction versus a product removing.

In keeping with a GlobalData report, Philips owns round 13% of the worldwide MRI gadget market – estimated to be $5.2bn in 2023.

In November 2023, the corporate launched three new MR Smart Fit coils that allow synthetic intelligence (AI)-powered software program and scale back setup and scanning time.


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