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FDA issues Class I recall of Philips' BrightView SPECT scanners

por John R. Fischer, Senior Reporter | February 08, 2024
Molecular Imaging
BrightView XCT SPECT/CT system (Photo courtesy of Philips)
The FDA has issued a Class I recall of Philips’ BrightView SPECT scanner following the discovery of a failure with the screw that can cause the system’s detector to shift downward under certain circumstances, creating the risk of it falling on patients.

The recall also includes X and XCT versions of the solution, which Philips stopped selling in 2014. Approximately 1,000 systems are still in use, according to a safety notice the company released. While no patient injuries or deaths have been reported, Philips decided to notify the authorities about the risk after receiving a complaint about it last year as part of its regular surveillance activities.

“If the detector is positioned below the center of the gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If the detector is positioned above the center of the gantry, there may be an interruption to normal system operation,” said the FDA in a statement.
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Additionally, the Australian Therapeutic Goods Administration has issued a Class II recall for the issue, saying that whether the detector is positioned below or above the gantry’s center, a rescan or reinjection of a radiopharmaceutical may be necessary, exposing patients to unnecessary imaging and radiation.

In a statement of its own, Philips said that users can continue using the system per the instructions it came with, and has also laid them out in the field safety notice. It says that it is “contacting customers to schedule an inspection of the system, implementation of an additional safety mechanism, and if necessary, replacement of the leadscrew,” and that it will “continue to invest in patient safety and quality.”

It is encouraging providers to show the notice to all individuals who use the device and keep it near BrightView SPECT systems until the correction is implemented for all.

The BrightView recall comes just after the company signed a consent decree with the U.S. Department of Justice which lays out the requirements for restoring compliance within its respironics business following the 2021 recall of over five million ventilators and several others that have followed over the last two and a half years. As part of the decree, Philips has agreed not to sell sleep and respiratory care devices in the U.S. for the next few years until compliance is restored, but will service products already in use among providers there. It will also continue sales abroad.

After the signing of the consent decree, the FDA revealed that over 500 reported deaths have been linked to the recalled ventilators and respirators from 2021.

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