Developers: | Philips Healthcare |
Branches: | Pharmaceuticals, Medicine, Healthcare |
2023: Recall of defective scanners
December 20, 2023 U.S. Food and Drug Administration (FDA) announces on the recall of magnetic resonance imaging Panorama devices 1.0T the company's HFO. Philips There is the potential for these scanners to explode during operation, which can cause serious injury or even death to people nearby.
The Panorama 1.0T HFO device is an open-type tomograph with a large field of view. This design makes the system as convenient as possible for patients with high levels of anxiety, obesity and fear of confined space. The apparatus allows a wide range of diagnostic examinations with high image imaging quality. In addition, in this tomograph it is allowed to examine the child together with the parent, which helps to solve the problem of tears and screams.
The FDA notice says the explosion of the Panorama 1.0T HFO MRI scanner may occur during the cooling procedure due to an excessive increase in the pressure of helium gas. For 22 years of operation of these systems (by the end of 2023), only one similar case was recorded, and no one was injured as a result of this incident.
The problem affects Panorama 1.0T HFO devices with model numbers 781250 and 781350. Such devices were delivered to the market from January 1, 2001 to October 1, 2016. All medical facilities in which such systems are installed are urged to stop operating them immediately, since further use of the devices can lead to the most severe consequences in the event of an explosion. Philips maintenance engineers will diagnose defective MRI devices and perform repairs if necessary.[1]