In more recall woes for Philips, 150 of its magnetic resonance imaging (MRI) scanners have been recalled due to being at risk of exploding.
Unlike many of Philips’ previous recalls centred around its respiratory device product line, the company sent out an urgent medical device correction to users of its Panorama 1.0T open MRI system after it found that the machines are at risk of excessive pressure build-up of helium gas.
The US Food and Drug Administration (FDA) tagged this recall as Class I – the most serious type of recall indicating that continued use of the devices may cause serious injuries or death.
According to an FDA alert on 20 December, the risk of explosion is during a quench – a procedure used to rapidly expel liquid cryogen to maintain the superconductivity of the MRI magnet. Equally, unintended quenches can also occur. The excessive build of pressure in either scenario could compromise the structural integrity of the device, the FDA said.
Patients could be exposed to chemicals and lack of oxygen in the event of an explosion, as well as traumatic injuries from the explosion itself. The FDA highlights tissue damage and mechanical trauma caused by debris – including the potential for brain injury and even death.
The FDA stated there has been one reported explosion during the system’s 22 years of use and no injuries or deaths to date.
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By GlobalData
Customers have been told to discontinue using the scanners. Philips also urged users not to perform a manual quench of the magnet except for emergency use.
The FDA highlighted the recall was a correction as opposed to a product removal.
According to a GlobalData report, Philips owns around 13% of the global MRI device market – estimated to be $5.2bn in 2023.
In November 2023, the company launched three new MR Smart Fit coils that enable artificial intelligence (AI)-powered software and reduce setup and scanning time.
