US FDA classifies Philips' recall of imaging machines as most serious

[February 16, 2024]  (Reuters) -The U.S. FDA said on Thursday it has classified a recall of Philips' medical imaging machines as most serious due to the risk of a detector in some devices unexpectedly falling on patients during scans.

Philips' recall of BrightView Imaging Systems, used for single photon emission computed tomography (SPECT) scan, is to correct the faulty component and not a product removal, the health regulator said.

A falling detector may cause a person to experience neck injury, contusion and traumatic brain injury, among others.

There has been one incident related to use of the device, but no reports of injuries or deaths, the FDA said.

Philips sent a letter to all its affected customers in December, requesting them not to position a patient's lower limbs directly under the detector. These devices were manufactured and distributed between September 2007 and June 2013.

"Philips is contacting customers to schedule an inspection of the system, implementation of an additional safety mechanism, and if necessary, a repair," the company told Reuters, adding that customers may continue to use their system, if they follow the safety instructions.

Dutch technology company Philips. logo is seen at company headquarters in Amsterdam, Netherlands, January 29, 2019. REUTERS/Eva Plevier/File Photo

Over 550 devices are being corrected by Philips in the United States, the FDA said.

The company, which stopped producing and selling the BrightView product in 2014, said the financial impact of the recall is negligible.

The Dutch health technology company over the last few years has recalled multiple other devices, including its ventilators, for which it reached a compliance agreement with the FDA last month.

(Reporting by Leroy Leo and Pratik Jain in Bengaluru; Editing by Shounak Dasgupta and Shinjini Ganguli)

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